Links to 651 Entry-Level Biotechnology & Life Science Jobs

The Process Development Associate I conducts laboratory experiments in a productive manner with consistent quality and timely outputs, under supervision. Responsibilities: Stays current with all training requirements. Follows procedures reliably and consistently. Sets up experiments, monitors, and acquires analytical data. Keeps detailed, accurate and clearly written records in accordance with GDPs. Establishes good working relationships with peers and other colleagues. Displays a positive attitude and good change readiness. Independently supports good lab hygiene. Recognizes and troubleshoots outcomes that are not aligned with expectations and seeks guidance as appropriate.

This Data Scientist Associate position is on the data science team at DZD, which is responsible for training machine learning models to predict antimicrobial resistance from genomic sequencing data and generally supporting data analytics across the company. The Data Science Associate can expect to be involved in model R&D (featurization, model specification and training, performance analysis, etc), as well as ad hoc analytics work and preparing models for deployment into production. Much of the work will involve interactions with software engineering and computational biology teams, and being able to work both collaboratively and independently are key.

Responsibilities: Perform and assist with sample processing toward diagnostic workflows. Design and carry out research and development experiments in collaboration with DZD lab team. Analyze and present experimental data for the R&D team. Maintain meticulous documentation of experimental outcomes and observations. Work closely with Research Scientists and Associates, and maintain close communication with direct supervisor. Repetitive workflows are a frequent occurrence.

Responsibilities: Build and reinforce the computational framework for processing various metagenomics projects with indications in human health. Work alongside bioinformaticians, computational biologists, engineers, and biologists in a highly collaborative environment. Learn existing biological databases and how we can leverage them into our platform. Analyze, improve, and maintain relational databases. Develop and maintain high quality revision-controlled code. Build docker images for complicated tasks.

Deep Genomics seeking a highly motivated bioinformatician with strong programming and scripting skills to help us advance their therapeutic programs to the next level. The successful candidate will work in a multidisciplinary team of biologists and computational scientists and take on tasks spanning analysis of experimental data, genomics data processing, and data visualization from a multitude of therapeutic programs. The ideal candidate would have a good understanding of molecular biology, human genetics, and basic statistics.

We are seeking a creative and experienced machine learning scientist to decipher how mutations and genetic medicines influence the molecular world of the cell. The successful candidate will develop machine learning approaches for modeling complex RNA- and protein-level outcomes based on massively parallel assays. The ideal candidate has a proven track record of publishing at top machine learning conferences (NIPS, ICML, ICLR) or has applied deep learning to genomics in a top life sciences journal.

You will be part of the DNA Operations group at Demetrix and will facilitate a variety of high throughput pipelines related to building and testing of microbial strains.  You will be part of an interdisciplinary team of scientists and engineers working to rapidly develop microbial strains to produce natural product medicines.

Dendreon Patient Operations manages the creation of the production plan and execution of arm-to-arm activities supporting Provenge treatments, including but not limited to production and demand planning, logistics analysis, scheduling, and real-time product monitoring. The primary focus of this position is to schedule and monitor patients treatment schedules according to the care providers preferences in a diverse call center environment while providing an exceptional customer experience throughout the entire process. 

Dice Molecules is seeking an exceptional full-time lab-based synthetic chemistry Research Associate / SeniorResearch Associate to join their medicinal chemistry team. This individual will be a key contributor to the synthesis of intermediates and final compounds within the goals of developing treatments for inflammatory diseases.

The Nuclear Medicine Technologist will work will work under the direct supervision of site physician, performing various duties related to nuclear stress testing.  Performs patient care functions related to perfusion imaging and stress testing at customer sites. 

DiscGenics is seeking a research associate who can support the raw material team by performing a variety of cell culture and chemical test methods as well as assisting with donor procurement. This is a laboratory position that will provide experience with cell culture and cell characterization methods. The ideal candidate will be driven and enthusiastic about our mission to aid patients with disc degeneration and have some experience with cell culture, cell based assays and chemical analysis. This role is intended to grow into a scientist position with increased independence and responsibilities.

Distek, Inc., a rapidly growing leader in the scientific instrumentation field is currently seeking a Validation Specialist in the New Jersey area to perform Instrumentation Services at customer sites. They will be responsible for validation, calibration, testing, installation, and repair or laboratory instruments.

The Manufacturing Engineer I is responsible for supporting projects that may include new products, new equipment, process and quality improvements, process validations, and cost reductions for internal manufacturing and sustaining activities at contract manufacturers. Responsibilities also include creating and/or reviewing work instructions, Engineering Configuration Notices, BOMs, item masters and label masters as required, and completing investigations of nonconformances and any resulting CAPAs.  

DNAnexus is looking for a bioinformatics scientist for their xVantage Care team to directly interact with clients to help them succeed with our cloud platform and solutions, and to proactively foster client relationships. 

As a software engineer of these applications, you will be responsible for creating products on the DNAnexus platform with the aim of delivering the best user and developer experience possible. You will contribute enhancements to our public library of apps and enable performance testing of these tools to make them highly available, scalable, fault tolerant and responsive. You will also be contributing to compilers for running workflows on DNAnexus that are written in open languages such as  WDL, CWL and Nextflow. To build these tools you will work closely with scientists and bioinformaticians within the company.

Covaris is seeking a dedicated individual who will be responsible of supporting day-to-day R&D laboratory operations. The candidate will be joining a dynamic group with a strong Team spirit. Main responsibilities will be maintenance of a functional, clean and safe laboratory. This includes equipment oversight following work instructions, organization of reagents and consumables including freezers and cold room. Opportunity to grow into a laboratory manager role.

Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC, UPLC, ICP, and UV-Vis. Responsibilities: Knowledge of USP and FDA requirements. Design and conduct full analysis of Dietary Supplements and Active Pharmaceutical Ingredients (API) products and their impurities. Conduct assay, content uniformity, dissolution, in-process blend, and blend uniformity of newly developed and stability samples in support of formulation and process development. Prepare result documentation for department and general review. Conduct Performance Qualification (PQ) on various instruments. Effectively communicate information in concise reports.

Responsibilities: Perform UPLC, HPLC, GC, UV-vis, FTIR, ICP, TOC and wet chemistry testing. Proficient in various UPLC and HPLC software programs, such as Empower and EZ-Chrom. Assist in writing SOPs and Test Procedures following good documentation practice per company's SOP and cGMP regulations. Assist in OOS investigations. Perform routine laboratory chemical analysis on finished product, stability and/or raw material, also involved in performing Cleaning, Method and Process validation. Troubleshoot basic instrument problems with supervision. Provide well-written, accurate and timely reports. Perform all work using appropriate safety measures and following company Chemical Hygiene Plan. 

Responsibilities: Maintain communication with QA Validation and PM Department to ensure that all requirements for validated products, with respect to manufacturing operations, are accurate, current, and complete. Ensure that the Job request list, conveys accurate and on-time issuance of production and non-commercial batches. Ensure Administrative Assistant work regarding batch issuance and all special instructions have been met. Request issuance of batches with related labels (bulk and IP). Updating production board accordingly. Perform check of all issued batches. Coordinate with Admin, IP batch folders for deduction, posting and filing for various stages.

Responsibilities: Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites. Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance. Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, eligibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety. Adapts and translates Patient Information Leaflets and Informed Consent Forms. Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues.

Responsibilities: Conduct sample analysis using various analytical techniques, including HPLC, UPLC, GC, KF, FT-IR, TLC, and LC-MS, GC-MS. Preparation of laboratory reagents and samples; operation of instruments; data analysis; preparation of analytical reports; notebook documentation. Support of various stability study protocols and execution of study tests. Contribute to the overall operations of the QC lab, including supplies inventory, lab safety, team meetings, responding to customer needs, etc. Perform LC/MS for compound characterization and identification with supervision. Maintain cGMP compliance in the laboratory.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner.

The Front Line Quality Assurance Specialist will provide on the floor support to manufacturing (bulk, sterile formulation/filling, and packaging), laboratories, utilities, maintenance, and logistics at the Holly Springs site. Core responsibilities of this role include quality walkthroughs on the floor, GMP record reviews and approvals, and real time triage of quality related issues.

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

Culture Biosciences is looking for a Bioprocess Associate to help run their cloud biomanufacturing facility. Your work will contribute to getting novel biotechnology products to market faster and more efficiently. You will have an opportunity to build new skills and learn about all aspects of their business. In particular, you will learn mammalian and microbial cell culture techniques and work with state-of-the-art robotics, software, and automation equipment.

Culture Biosciences is looking for a Hardware Engineer. Your focus will be on designing, building, installing, and testing new cloud connected bioreactors and lab automation.

Curi is a rapidly growing startup company seeking a talented and motivated Research Associate to join their R&D team. A successful candidate will have extensive expertise in cell culture, knowledge of iPSC biology, and experience with standard cell biology assays. Experience in developing assays is highly desired. Knowledge of genome editing and tissue engineering techniques would be beneficial.

Perform assigned laboratory testing and related quality control activities in order to ensure compliance with applicable SOP's and cGMPs. Provide timely testing and notification of any aberrant occurrence to Management/Supervision that presents potential negative impact to manufactured or marketed product. May supervise the work of others and coordinate instrumentation use and completion of laboratory testing. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. 

Perform assigned quality control activities within the Microbiology Department in order to comply with applicable SOP's and cGMPs. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Must have the ability to work collaboratively, multitask, and adapt to changing priorities and schedules.

Perform routine Quality Control testing in accordance with Analytical methods and applicable SOP’s and cGMP’s. Perform assigned QC laboratory tasks by the required due dates. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Must have the ability to work collaboratively, multitask, and adapt to changing priorities and schedules. 

Performs all tasks associated with aseptic manufacturing of radiopharmaceuticals in an ISO 5 cleanroom environment according to cGMP guidelines and to meet production demands. Tasks include (not limited to) preparing sterilized equipment and components, controlled environment/ equipment cleaning and maintenance, and formulation and dispensing of final product.

Responsibilities: Perform routine in-vitro biological, biochemical, or assays. Responsible for planning, performing and reporting in vitro screening assays for discovery and development stage compounds. Ability to perform high-impact as well as high throughput studies to completion in a fast paced environment, while managing multiple projects to meet the timelines. Assist in data analysis when needed. Laboratory support including ordering, equipment calibration and validation. Working to a high standard and adhering to our Quality System. Work closely with the Project Managers to ensure the requirements of our clients are met. Assist in running and maintaining robotic systems to support processes. Identify where support is required and manage their own time sufficiently to provide this support.

Major Job responsibilities will be manual solid sample weighing and solubilization of the solid samples using an automated liquid handler. The position requires a highly motivated individual, able to work independently, and as part of a team, to ensure successful project support. This role will be expected to have increased understanding of Compound Management workflows, set forth SOPs, etc. Tasks will include but is not limited to performing the day to day laboratory work and direct communication with local and remote lab colleagues in a cross-functional environment.

The candidate will join a cross-functional team responsible driving science forward through engineering optimal expression of recombinant proteins in bacterial expression systems. Candidates will be responsible for the expression of a range of protein targets within the pharmaceutical arena.

The QA Operations Associate I is responsible for maintaining quality oversight of operational areas by working closely with Operation’s personnel and performing various checks during manufacturing processes to ensure that current Good Manufacturing Practices (cGMP’s) are followed. The QA Operations Associate I also assess regulatory and quality risks in activities and processes according to GMP and Cytovance Standard Operating Procedures. 

The Clinical Lab Associate will be responsible for assisting in routine sample processing for a night shift (10 PM - 6AM, 4 days) in a highly automated, high complexity CLIA-certified laboratory, and you will be working with other laboratory professionals who have joined Color from UCSF, Stanford, Invitae, Counsyl, and other academic and commercial laboratories. Your work will have a direct impact on people’s lives by scaling up the availability of COVID-19 testing and developing much needed public health infrastructure.

The CAD Engineer I will be responsible for designing and reviewing patient-specific implants and surgical instruments using various software packages while ensuring Conformis quality standards.

The Research Associate will contribute to the culturing, plating, distribution, maintenance, and banking of cell culture lines, including primary cells and stem cells, as well as immunostaining and imaging these cells within the Research and Development group at a fast-paced start-up company in Cleveland, Ohio to support drug development efforts in the area of remyelination. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and leading with minimal supervision. As a team member of the R&D group you will work to support cell and tissue culture activities and cellular assays that serve as critical points in a drug screening cascade.

This position is responsible for providing statistical expertise to clinical development programs. The Biostatistician applies statistical methodology to ensure that the clinical trial designs, programming, and analyses are statistically valid and meet the recognized international standards.

The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products. Responsibilities: Interface with Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians as necessary to progress projects/tasks. Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals. Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable. Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.

CooperSurgical is seeking to hire a laboratory technician for full time employment in a large-scale culture media manufacturing facility. Candidate will be involved in a wide range of process tasks from maintaining an ISO certified cleanroom to final product. 

The Product Surveillance Associate II reviews, evaluates, and investigates product complaints relative to the identity, quality, reliability, safety, and effectiveness  of CooperSurgical Medical Device and Invitro Fertilization products. The Product Surveillance Associate II is experienced in complaint handling activities and categorizing complaints to comply with current FDA and international reporting regulations.  Duties also include supporting the intake of complaints from various sources, initial screening of essential complaint details, Good Faith Effort Follow ups for additional information, Medical Device Reporting (MDR)/Medical Device Vigilance (MDV) determination, investigation assignment, as well as various complaint process activities.  In addition to, supporting recall and related field actions in the form of preparing technical documentation and coordinating associated activities.

The Field Service Engineer is responsible for administering preventative maintenance (PM) and troubleshooting, calibrating and performing electrical safety tests (EST) on automate microbiology equipment primarily located but not limited to Midwest area of the United States. The ideal candidate is involved in all areas of microbiology equipment technology, including monitoring work order requests, completing repairs, new equipment inspections and installations, PM’s, EST, inventory management, and documenting all service activities.

Responsibilities: Work closely with project management and clients to establish required specifications for manufacturing materials from approved vendors and ensure sourced materials are available when required. Ensure materials are sampled by Quality Control and tested per the approved specifications. Work closely with the Quality Unit to ensure results for material testing are completed and submitted for approval in order to release for use in manufacturing. Support projects by locating sources and completing purchase orders as per the established internal processes and procedures. Assist Purchasing with vendor management; factoring in costs, customer service, availability of materials and assessing reliability.

NorthEast Biolab is looking for a recent graduate for a lab position in Camden, CT. Duties: Support implementation of Laboratory Information management System (Watson LIMS) for sample management and storage; Sample management and reconciliation, kit preparation and verification, and document preparation related to biological sample collection, storage, and shipment for clinical trials; Streamline inventory management, consumable ordering, and other documentation requests for Quality Assurance Unit; Help maintain ultra-low temperature (ULT) freezers and refrigerators and associated electronic logs and records; Learn bioanalytical techniques for the analysis of drug and biomarkers in biological matrices

The Chemist I position is responsible for receiving and testing raw materials.  Supports laboratory investigations, CoA reviews. The Chemist I plays a crucial role in the Patient First philosophy by analyzing raw material samples and reporting accurate, precise test results in a timely manner to our internal customers.  These results ensure our products are made safe, effective and delivered on time to patients.

The incumbent will be involved in all aspects of the overall operation of our clinical studies including project planning, budget, resource management and CRO management. Responsibilities: Daily operations of studies to ensure compliance with applicable GCP/ICH guidelines and other regulatory requirements. Work with cross-functional study teams, including vendors; liaise with other functional areas (preclinical, manufacturing, regulatory affairs) in order to accurately coordinate clinical study activities. Coordinate clinical study timelines with project leaders to meet critical milestones; escalate issues that may jeopardize timelines and deliverables. Track study monitoring visits and co-monitoring visits as needed. Provide updates of study progression.

The Clinical Trial Assistant provides technical and administrative support to the clinical project team during all stages of a clinical trial by carrying out administrative in-house-activities. The CTA administers, maintains and coordinates the logistical aspects of clinical trials with a high attention to detail by producing and reviewing documentation, coordinating project details, and maintaining data and filing systems - all with the sense of urgency expected of CATO SMS customers.

The Research Associate, Cell Engineering, will support activities to advance our universal iPSC-derived allogeneic cell products for targeting hematological and solid tumors. The Research Associate will be responsible for utilizing existing cell engineering methodologies for gene editing in iPSCs in support of cell therapy efforts. The ideal candidate will work closely with research colleagues, collaborate across functional groups, be self-motivated and able to perform in a fast-paced setting.

Associate will perform laboratory tasks in support of flow cytometry assay development for R&D team. Duties and responsibilities: Preparation and handling of primary specimens, including peripheral blood, tumors and other biospecimens. Isolation of PBMC by density gradient separation. Sample preparation (murine or human tissues/cells) for Flow Cytometry and Immunostaining or other assays. Isolation of cell populations with magnetic beads. Assists with ex vivo and in vitro assays with endpoints (e.g. ELISA, cytotoxicity, cytokine profiling). Cell culture experience with cell lines and/or primary cells. Troubleshoot, optimize, and develop methods for unmet experimental needs. Maintain laboratory records and notebook, organize and compile data, and write weekly reports on results. Assist with other tasks/duties/projects as needed.

As a Research Technician in Study Services, you will support in vivo oncology studies in mice. Additional duties and responsibilities include: Perform in-life technical procedures, handle, restrain, and provide care for all animals. Observe animals for general health and overall well-being. Administer therapeutic agents by various routes. Provide animal welfare assessments, including body weight and tumor volume measurement. Allocate animals to study and non-study groups. Provide preoperative animal care. Euthanize animals as directed in study protocols and directives. Read study protocols and extract pertinent information. Perform study preparation activities including collection tube labeling and room/BSC set-up. Record data using laboratory information management systems.

As a Research Technician in Necropsy you will support the in vivo oncology studies in mice as well as properly euthanize animals in accordance to the company standards and regulations. Additional responsibilities include: Allocate animals to study. Assist with gross necropsies (dissection, tissue trimming/collection/preservation, sample collection). Perform preparation activities, including container and tube labeling and room set-up. Collect, process and maintain blood and tissue samples. Use appropriate anatomic terms and descriptors for lesions. Assist with the tracking and shipment of samples to sponsors and diagnostic laboratories. Conduct and record data in compliance with Standard Operating Procedures (SOPs). Read study protocols and extract pertinent information. Record data using laboratory information management systems.

This position will support the downstream purification team for development and implementation of a fully integrated end to end continuous bio-production platform fully enabled with PAT. This position will focus on evaluating continuous operation technologies using quality by design techniques, to develop and optimize novel, continuous recovery and purification processes, for recombinant proteins and biological macromolecules. The applicant should have experience in laboratory research, and a desire to continue in a laboratory-focused role. The position will interface with a small team of scientist and engineers focused on continuous chromatography process development and technology transfer to demonstration scale production.

This is an entry level position in which the applicant's primary responsibility will be to support the development and commercialization of Circulomics technologies including Nanobind, Short Read Eliminator and PicoSep. This work will involve significant exposure to various next-generation sequencing platforms, in particular long-read sequencing technologies from PacBio and Oxford Nanopore. Applicants that show a high degree of independence and aptitude can be expected to gain responsibility quickly and acquire new opportunities.

The Laboratory Coordinator play a crucial role in the execution of clinical research protocols. The overriding purpose of this position is to process and store study biospecimens and assists the operations teams in the growing needs of the studies’ additional lab-related requests.

Responsibilities: Assist in establishment and management of contracts submission process and timelines to exceed customer expectations and facilitate an efficient, high quality, and timely submission. Coordinate and prepare budget and contract revisions with Operations Directors, Project Manager, DBD, Project Analyst. Assist Project Managers and DBDs with scope change review with sponsors as needed. Contributes to establishment of payment terms on contracts and change orders with Finance and Legal as needed. Serve as a financial resource to Project Managers or other project team members. Periodic review of project finances, hours, units and milestones to ensure no missed change order opportunities. Partner with the Finance department to assess profit margin and ensure change order proposals capture costs. May need to attend and prepare content for project or company review meetings. Participate in quality or process improvement initiatives.

The Pharmacovigilance Specialist (PVS) primary responsibility is SAE case management. This includes but is not limited to: initial case disposition, confirmation of case disposition with Medical Monitor (MM)/Safety Physician PV (SP PV), MM, receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management and reporting according to regulatory requirements. All activities will be in accordance with Clinipace and/or client SOPs, ICH Guidelines and local regulatory requirements.

The Associate Formulation Scientist I will support the Associate Manager Formulation Development by assembling, operating, and cleaning processing equipment; preparing coating solutions and other formulas; and performing various analytical testing including but not limited to particle size testing, moisture analysis, and equipment cleanliness verification. The Associate Formulation Scientist I will also work with the Associate Manager Formulation Development to plan and support various pharmaceutical, supplement, food, and industrial projects and will contribute to the development, scale up, and production scale processing as directed by the Associate Manager Formulation Development. 

The primary purpose of the QC Associate Scientist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples.  Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, research procedures, and miscellaneous protocols.  The Associate Scientist is expected to understand internal procedures and reliably conduct analyses with limited supervision.

The primary purpose of the QC Analytical Chemist 2 is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples.  Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, research procedures, and miscellaneous protocols.  The QC Analytical Chemist 2 is expected to understand internal procedures and reliably conduct analyses with minimal supervision.

Responsibilities: In collaboration with cross-functional project team members, perform high-throughput (HTP) screening campaigns to support directed evolution of next-generation biotherapeutics. Express recombinant protein variants in E. coli or mammalian cells for in vitro profiling. Execute and troubleshoot assay protocols for protein characterization (e.g., biochemical, enzyme activity, and cell-based assays). Adapt assays for HTP screening. Actively participate in project teams, present research updates, and collaborate with cross-functional team member. Maintain a safe and efficient workplace, follow safe lab practices, keep diligent records, and write reports and SOPs as needed.

As a Technical Support Engineer, you will report to the Head of IT. As a member of the IT team, you will be responsible for ensuring timely and accurate resolution of technical issues for Codiak’s employees.  You will also contribute to the initiatives to improve efficiency and service levels.

Responsibilities: Review manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc. Perform line clearance and provide general manufacturing support. Supports product shipment and receipt of returns. Support raw material review and disposition. Review Building Management Systems reports. Participate in departmental and cross-functional continuous improvement efforts. Consistently set a high standard for quality of work. Promote a safety mindset through daily actions and communication with team members.

You will be responsible for design control compliance for assigned products and will support development and execution of regulatory strategies per time lines to assure clearance / approval in the assigned geographies. In this role, you will also prepare, monitor and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, change analysis, claims review and vigilance reporting.

The Microbiologist will be responsible for daily testing of microbiology samples, water testing, and for other duties as assigned. Responsibilities: Provide laboratory testing support for the Cambrex Charles City Quality Control group. Perform chemical testing with supervision using analytical instrumentation including TOC, conductivity meter, and Endotoxin reader. Perform chemical testing with supervision using standard compendial test methods such as identification, microbial analysis, etc. Write and execute microbial methods and validation protocols. Adhering to SOPs and regulatory systems as they relate to laboratory testing operations; e.g. cGMP compliance and training.

An ideal candidate for our Clinical Project Associate position is an individual who has the ability to prioritize and multitask, is experienced in Microsoft Operating Systems, and possesses strong organizational and communication skills. Responsibilities: Support the project team on designated projects ensuring that customer service, quality, and timelines are met. Perform quality control checks to ensure the integrity of data. Aid in the preparation of supply shipments to study sites. Setup, maintain, and update databases and assist with data query resolution. Ensure proper filing of all study documents and under direct supervision communicate with study sites by fielding, answering, and directing questions to obtain appropriate answers.

Responsibilities: Assist in the assembly of regulatory information for submission. Adheres to the client's defined submission preparation timelines. Searches document and change management databases for historical data/information that need to be captured in the updated regulatory submission. Using the client's templates for dossier sections, author CMC sections for routine submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including adding technical data and descriptive text.

Nuclear Pharmacy is responsible for providing radiopharmaceuticals and other drugs to medical care providers under highly regulated State and Federal guidelines; may also consult with or advise physicians and nuclear medicine technologists on the safe and efficacious use of radioactive drugs for diagnosis and therapy

Working with the US Sales & Marketing team in a collaborative and cross-functional setting, the Field Clinical Specialist will participate with the US Sales & Marketing team in the field support and education using the Company’s unique Endoscopic Ablation System in the treatment of patients with atrial fibrillation (AF).

The Clinical Laboratory Scientist (CLS) performs testing in the CLIA-certified laboratory, participates in quality control, quality assurance and troubleshooting activities. A CLS performs duties under general direction, carrying out work assignments in accordance with policies and objectives established by the Clinical Laboratory Manager (CLM)or designee. A CLS is expected to plan and organize his or her own work, determining work methods and assisting in the determination of priorities and deadlines. Completed work is reviewed by the CLM or designee to verify the achievement of expected results.

Responsibilities: Define surgical steps and tasks to break down the surgical videos for technical assessments for surgeons. Ensure security of PHI from the surgical videos and surgeon’s information with acute attention to detail when handling sensitive data. Build innovative surgical content to help educate surgeons across all surgical methods and procedures. Accountable for the delivery of critical business projects, continuously ensuring alignment and prioritization of C-SATS objectives with business needs. S/he must establish and maintain a positive, proactive, high-energy, collaborative and engaging work environment. Collaborate with R&D and Machine Learning organization to help implement integrative technology to process surgical procedures efficiently.

The Associate Scientist I will be a member of a formulation/process development team within the Drug Product Development (DPD) – BioTherapeutics (BioTD) department.  The Associate Scientist I will be involved with DPD activities related to implementation of fill/finish processing at the development stage and manufacturing scale pertaining to monoclonal antibodies, cell-based therapies and virus like modalities to name a few. 

Responsibilities: Learn and apply state-of-the-art drug discovery approaches as part of a dynamic, multidisciplinary cellular assays team. Develop and implement innovative cell-based assays to identify and evaluate lead compounds using high-content imaging, gene expression profiling, 3D cell culture and/or co-culture methods. Work closely with computational biology colleagues to analyze high-content data and identify promising leads compounds. Attend and present data at program team meetings and in-house seminars. Publish research in high-quality journals, as appropriate.

This role represents an exciting opportunity for a candidate who wants to work on building groundbreaking surgical capabilities for Orthopaedic Robotics. The Electrical Engineer will work on a new Surgical Robot for Orthopaedic Surgery from the development phase through commercial release, as well as future robots.

In this role, you have the opportunity to work on some of the most complex challenges in healthcare by utilizing your skills in data structures, systems knowledge, algorithms, and object oriented programming.  As a field service engineer at Philips, you are the bridge between abstract concepts and the technology products used daily to touch the lives millions of other people around the world.

The Cleaning and Disinfection Test Engineer focus is to generate C&D test protocols, conduct testing internally and externally and document results. Responsibilities: Assess failures and coordinate corrective actions with project teams. Review product requirements with development teams to ensure that they are complete and testable. Coordinate C&D Formal Technical Reviews with cross functional group to plan and execute strategies. Interact with Technical Writers to ensure product labeling complies with executed test procedures.  

Research Associates are responsible for conducting scientific research leading to the discovery and development of high value, proprietary molecular diagnostic products and related technologies.  A strong understanding of molecular biology, molecular genetics, aptamer development and validations is highly preferred.

A Quality Assurance Technologist is responsible for a multitude of different tasks within the clinical molecular laboratory including the quality control testing of all molecular reagents prior to use on clinical samples, assisting the product development team with the validation of new assays and training current employees on new assays as well as new employees on established assays This position is required to be well versed in various molecular techniques that include, formalin-fixed paraffin-embedded tissue macro-dissection, RNA/DNA extractions, PCR, RFLP, DNA methylation analysis, Next Generation sequencing and automated liquid handlers. Quality Assurance Technologists are expected to contribute technically and intellectually to enhance efficiency within the lab while ensuring that the quality of reagents and training program is maintained to the highest standard. This position works under the direction of the Director and follows standard laboratory procedures and policies.

Bioinformatics scientists provide bioinformatics and statistical analysis support for biomarker discovery, IVD product development and CMI tumor molecular profiling service. Responsibilities: Develop and maintain statistical analytical tools and bioinformatics pipelines. Conduct analysis and develop innovative algorithms on biomarker discovery and clinical diagnostics data. Consult on experiment design and data interpretation for laboratory research. Provide analytical support for quality assessment of laboratory service and production data. Contribute to design and development of informatics infrastructure. Adhere to coding and documentation standards and manage deliverables for area of responsibility.

Responsibilities: Support preparation of engineered red blood cell extracellular vesicles (RBCEVs). Perform cell culture experiments to characterize RBCEVs. Support animal studies from dosing to downstream sample processing and analysis. Perform immunohistochemistry and in-situ hybridization experiments. Analyze and interpret experimental data. Maintain accurate and detailed documentation including electronic lab notebook. General laboratory assistance including organizing lab supplies, preparation of reagents, and lab equipment maintenance. Present research findings in the internal meetings.

The successful candidate will perform various tasks to support AD analysts, including Reagent Preparation, Inventory Maintenance/Ordering and maintenance of GMP notebooks/records. The Laboratory Assistant is expected to assist various groups within Analytical Development and help with maintenance of GMP compliance in multiple laboratories within AD.

This role will be responsible for working with our Quality Engineering team to ensure each deviation is thoroughly investigated and quality impact assessed. Specific Responsibilities: Supports the manufacturing of pharmaceutical products. Conduct direct contact with clients and internal customers across the site. Ensure that documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities. Suggest Corrective and Preventative Actions (CAPAs), take ownership for their deviations and drive to meet deadlines. Perform Root Cause Analysis and Investigations in Trackwise.

You will work within a highly dynamic group serving as a resource for implementation, expansion and enhancement of automation solutions used in Manufacturing and Fill/Finish Operations. You will play a key role in expanding the use of Automation to increase manufacturing efficiency.

This position is responsible for the production of Animal free cell paste by means of various types of bioreactor/fermentation systems. Work in a highly regulated, GMP, cleanroom environment. Generate cell banks, performs small- and large-scale fermentation for protein production.ﾠ Analyze productivity as required, based on SDS PAGE Gels, bioassay results and Western blots.ﾠ Provide documentation of performed tasks and assists in establishing written procedures to accurately document production of protein. Assist with the purification and final bottling of products as time allows.

Quality Technician- Statistics has the ability to work independently, analyze results and determine whether product specifications are met. Technician participates in instrument lab maintenance activities, by consistently monitoring laboratory and process inventories and conducting log book and device history record review. In addition to Quality Technician responsibilities, Quality Technician- Statistics is the primary person responsible for the efficient operation of the Statistical Program database for all OEM, RNA or Hospital customers.

Responsibilities: Execute RNAscope/BaseScope/miRNAscope-based assays to support new product development and assay optimization, including but not limited to RNAScope/BaseScope/miRNAscope assay testing, R&D collaboration projects and RUO raw material improvement projects. Support manufacturing QC for commercial product testing, release and troubleshooting when needed. Facilitate SOP/SPK/SPJ drafting/assay QC procedure transfer from R&D to QC team. Participate in R&D/QC communication and hands-on training. Responsible for experimental design, assay running, data collection and interpretation. Maintain sample inventory and logs for slides.

The focus of this position is to provide support for assay development and testing to characterize lentiviral vector, drug product, and genome editing reagents. Responsibilities: Design and perform experiments to support the development of analytical assays for molecular characterization of lentiviral vectors, mRNA, and cell therapy products. Learn and implement new laboratory techniques and equipment. Perform general laboratory tasks including ordering, reagent preparation, and equipment maintenance. Generate, manage, evaluate, and maintain critical data in a highly organized manner including lab notebook maintenance with good documentation practices.

Responsibilities: Perform cGMP Microbial testing (Environmental Monitoring, Compressed Gas sampling and testing, and water collection). Follow procedures and provide direction on deviations from the norms. Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization. Implement and support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training). Participate in providing the necessary information for regulatory filings and inspections.

Responsibilities: Participates in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs. Supports complex clinical trial activities in support of the Clinical Study Manager and other team members. Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.). Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management. Ensures tracking of patient status throughout the study at investigative sites. Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule. Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting.

The Design Assurance Engineer I is a quality engineer that supports medical device product development from concept through commercialization as a member of the Compliance and Continuous Improvement team.ﾠ This position will work with high-performance, cross-functional teams to optimize and maintain quality systems procedures, tools, and guidance that support the execution of Design Control, Risk Management, and Post-Market Surveillance within Interventional Cardiology.ﾠﾠ

The Electronic Technician performs skilled-level testing, maintenance and repair. The testing is performed on PCB level and finished product, using protocols and direction from Engineering staff. Responsibilities: Maintains and repairs electronic equipment. Evaluates and documents custom designed systems. Uses protocols and procedures to build and perform test and repairs. Documents test changes and test results in electronic format. Consults with team members for both new and existing test systems. Advises design engineers on issues that may occur when performing the testing. Track time, materials, and other job-related data.

The successful candidate will be a project leader in the improvement of the Peripheral Interventions (PI) division global product performance analytics, interacting with all divisions and partner functions to ensure alignment and the best predictive methods are employed. This role will have technical leadership responsibilities for the development and implementation of analytical programs improving compliance and product performance. The individual will be a key participant in the establishment and implementation of a Data Analytics Strategy.ﾠ

Responsibilities: Provide on-site consulting, guidance and assistance to physicians and OR personnel by evaluating options and problem-solving during surgery in order to maximize IGS (ImageﾠGuided Surgery)ﾠproduct efficiency and usage. Analyze, resolve and repair product issues through detailed analysis and utilization of engineering expertise. Direct and assist Radiology staff in performing necessary scans prior to surgery. Educate/train physicians and hospital personnel, including OR staff, Radiology, Central Sterile Processing, Biomedical and Information Technologies staff, on the use of IGS products and services. Develop and conduct training programs for hospital staff enabling them to implement in-house training. Act as primary customer liaison, maintaining contact with customer, assessing satisfaction and usage levels, and working to increase revenue via the sale of spare parts, upgrades, etc. Work closely with the Senior Application Consultant, Area Account Manager, Key Account Manager and Marketing Manager on market transparency, upgrade initiatives and R&D projects.

Brainlab's Application Consultants perform custom installations and provide consultation and guidance for customers utilizing the company's product portfolio. Responsibilities: Conduct on-site clinical evaluations for new and existing customers to demonstrate the use of products and services to increase the frequency and quality of IGS (Image Guided Surgery) product usage. Provide on-site consulting, guidance, and assistance to physicians and OR personnel by evaluating options and problem-solving during surgery in order to maximize IGS (Image Guided Surgery)ﾠefficiency and usage. Lead installations and establish functionality at new and existing customer sites. Educate/train physicians and hospital personnel, including OR staff, Radiology, Central Sterile Processing, Biomedical and Information Technologies staff, on the use of IGS (Image Guided Surgery) products and services.

Responsibilities: Performs assays and lab procedures related to Multiplex IHC assays including fluorescent imaging, antibody staining, PBMC isolation, and tissue sectioning according to SOPs using appropriate laboratory techniques. Performs various molecular biology techniques including but not limited to nucleic acid purification and QC analysis. Maintains laboratory notebooks, SOP documents, and computer databases. Performs sample intake and accessioning. Manages, monitors, and maintains equipment, facilities, and supplies. This will include routine handling and lifting of laboratory supplies and bench-top equipment. Works in a professional and collaborative manner with coworkers and customers. Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance.

This role serves as the day-to-day owner of the machine processes and process control systems for the plant. Owns and manages the development of troubleshooting skills of the manufacturing professionals. Acts as a subject matter expert for the machine processes. Participates and/or leads in Continuous Improvement projects. Helps to identify and support projects that will improve productivity, waste, quality and safety performance on a long term basis.

The QC Supervisor supervises the daily work of the Technologists in the Reagent QC group. This includes oversight of the employees, processes, and product while providing support to their team. Ensures daily and weekly tasks are completed including decontamination and housekeeping, participation in the swabbing program, and overseeing the processing of IVD product. Supervises performance of team members to ensure personnel matters are addressed and works with the Manager to resolve issues or pursue corrective action as necessary. Interacts with QA, BioMath, Manufacturing, Incoming QC, Engineering, Transfer Support, IQC, Software, Facilities, and other applicable departments to resolve product, process, and equipment issues. Creates and maintains a daily schedule of work performed by individuals to help manage capacity effectively and ensure rotation of job tasks. Ensures safety of Technologists working in a laboratory environment.

The Epidemiologist’s primary responsibility is to provide expert methodological guidance and support for the Global Medical Affairs team. This will include review of scientific study protocols for externally and internally developed studies to support the clinical and economic value of BioFire in vitro diagnostic products. Additionally, other responsibilities include contributing to the execution of internally developed studies. The Epidemiologist must stay up-to-date with the scientific and medical knowledge related to infectious disease and actively participated in the design of Health Economic and Outcome Research (HEOR) to ensure that the results of the studies will better inform medical practice related to BioFire’s products.   Position may manage Clinical Research Associates or Clinical Coordinators.

Responsibilities: Work cross-functionally with regulatory specialists, key internal departments, and external regulatory bodies to support product submissions. Coordinate and collect information from various departments (e.g., R&D, Clinical, QA, Engineering, etc.) to support regulatory projects, as needed. Coordinate and respond to requests from global regulatory agencies. Assist with regulatory assessments and strategies for proposed change notifications international jurisdictions. Process notarization & legalization of registration documents. Maintain and organize department spreadsheets.

As part of the Industrialization Analytical department, the Associate Process Scientist (Biochemist) will perform projects to support the manufacturing of BACT/ALERT® Culture Media products. Within this role the Associate Process Scientist will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, and other functions as required in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands.

The primary purpose of this position is to prepare complex chemical media and/or sub components, dispensing system setup/verifications, insuring timely delivery of high quality product to Card production, being current on training including curriculum procedures, work station organization and cleaning, establishing a safe work environment, housekeeping and maintenance functions in the production department

BioLegend has an immediate opening for a Quality Control Associate that will be responsible for testing products such as antibodies and proteins in the following application(s): flow cytometry, immunohistochemistry, western blotting, ELISA, multiplex immunoassays and/or functional bioassays. This position will also perform all aspects of the assays following SOPs and ISO requirements. Additional responsibilities include culturing mammalian cell lines, isolating primary cells, and maintaining laboratory equipment and supplies.

The Biochemist will be an integral member of a team, that manufactures and provides purified antibodies to enable studies for novel applications in precision medicine, oncology, immunology, neuroscience, and stem cell research. This position will report to a team lead and will ensure the highest quality of our finalized antibody products. This is a great opportunity to work in a fast-paced and dynamic environment for you to enhance your knowledge in the biotechnology industry! In this position you will perform column chromatography, troubleshooting of problematic errors, continue to improve methodologies for efficiency, follow Standard Operating Procedures (SOP)s, and cross train on a variety of other supporting tasks.

This position is responsible for developing cutting edge recombinant protein research products in Molecular Cellular Biology group. The research associate will be involved on developing a new line of recombinant protein products by supporting other team members. The duties include preparing buffer solutions and cell culture media, performing PCR and DNA purification according to standard operating procedures, performing bacterial and mammalian cells cultures, and purifying recombinant proteins with affinity tag. This position offers a significant opportunity for learning molecular biology techniques and career growth in the biotechnology industry.

This position is responsible for making custom multiplex immunoassay products in the Biomarker Immunoassay group. The Research Associate will be working with an experienced scientist and will be involved in all aspects of custom assay production processes including planning, manufacturing, testing, troubleshooting, optimizing and product order fulfilment. The customized products are an indispensable part of our bead-based immunoassay product portfolio and are complementary to the on shelf products. These products may allow simultaneously detection of up to 13 important biomarkers for inflammatory diseases, cancer, cardiovascular disease or neuron degenerative disease and will be very useful tools for the biomedical research community. This position is a great opportunity for gaining working experiences in a fast-paced biotech industrial environment

Bio-Rad is looking for Research Associate to work in the R&D Hematology Development group. The position requires a working knowledge of laboratory experimentation, general chemistry, and clinical chemistry. This position will assist and support the development of hematology controls. The ideal candidate will also possess abilities in data input, data processing, statistical analysis, and is comfortable working with blood, serum, urine and/or their various components.

Position primarily involves the safe and efficient manufacturing of API’s according to cGMP requirements. The role of Production Scientist, Associate is primarily focused on performing required production operations to support the end users and patients of the compounds produced at MilliporeSigma. These responsibilities include but are not limited to executing existing production procedures, updating ancillary documents, and maintaining the safety and quality of the manufacturing environment.

This role will perform a variety of testing, media and solution preparation, troubleshooting, and diagnostic tasks to ensure compliance with quality standards. The individual shares responsibility for lab equipment maintenance, housekeeping and other lab support functions while ensuring compliance with all established quality requirements, standards and maintains the lab in an audit-ready state. The candidate will demonstrate the ability to work well in a team environment and to exhibit sound judgment in non-routine situations. Willingness to support challenging goals to achieve superior performance are a must. Individual will anticipate and suggest solutions for risks to compliance and efficiency. Candidate will provide support for continuous improvement projects (validations, change control, process improvements). Primary commitment to safety and product quality by maintaining compliance to the Quality policy and other documented safety and quality processes and procedures.

The Associate Production Scientist will manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Responsibilities: Perform operations to meet quality expectations. Ensure quality throughout the process. Assure you are adequately trained to perform tasks/assignments. Perform routine assays, processes and/or unit operations. Complete the volume of work required to achieve group/departmental goals and meet deadlines. Contribute to support functions of the lab (e.g., maintain equipment, prepare reagents, restock lab supplies, waste disposal). Communicate the status of operations and bring deviations to the attention of supervisor.

Under direct supervision, perform routine laboratory operations associated with the manufacture and packaging of cell culture media and reagents for Life Science business unit resulting in customer satisfaction. Partner with R&D, Technical Transfer, Planning, Production, Quality Control, and Distribution to manufacture and assemble products in final configuration to meet customer needs.

This role is responsible for the manufacturing of Controlled Pored Glass (CPG) materials by following established and robust protocols. CPG material manufacturing would include amine and nucleoside modification of native CPG at various angstrom sizes as well as modification with proprietary dyes and quenchers. The CPG Tech I will also be responsible for the manufacturing, upkeep, and repair of basic CPG reactors used in these processes.

The Diagnostic Oligo Manufacturing Technician I position is responsible for manufacture of GMP-grade oligonucleotides for customers preforming mission critical diagnostic testing and research. Production laboratories include DNA synthesis, HPLC purification, mass spectrometry, and formulation. Technicians are expected to perform manufacturing activities in compliance with company procedures and external regulatory requirements as directed by the departmental supervisor, manager or director.

The Lab Research Technician will work within a team of highly motivated laboratory staff and scientists. This role will have a significant impact on the team’s progress through direct involvement in specific projects and support the daily operations in the Research Services lab. The chief role of this employee is to assist senior laboratory personnel with administrative lab duties and with protein expression and purification activities. The job involves performing sanitation and sterilization of labware, assisting with inventory management & equipment maintenance. The successful candidate should also understand and be able to apply basic molecular biology and protein chemistry techniques.  

Responsibilities: As a member of the Surgical Robotics Instruments and Accessories Integration Team, you will contribute to the development and support of robotic instrumentation for a surgical robotic platform. Progress development of novel instrumentation spanning from feasibility through to product launch. Solve and perform rout cause analysis of failures seen when instrumentation are used with the Robotics Platform. Build multi-functional relationships with a multitude of different department representatives. Design and create prototypes using in-house rapid prototyping capabilities. Provide hands-on, troubleshooting, process and manufacturing support as well as designing, implementing, integrating and testing solutions in a fast pace environment with a quick development cycle. Create design solutions utilizing engineering methods with good documentation processes, releasing design documentation through an ECO process in accordance with the company design control process.

Ensures customer and regulatory requirements have been met by inspecting incoming raw materials and review of documentation. Ensures compliance with all applicable standards and regulations (e.g., ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs).

Responsibilities: Conducts routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations and final products to established specifications. Utilizes and operates laboratory equipment and instruments according to laboratory work instruction or laboratory procedures such as pH, conductivity, UV, KF, FTIR and titrations. Ability to understand and follow Quality Control test methods or compendia methods (USP, EP, BP, JP or ACS) and EXCIPACT standard. Calculates and generates data for compliance to specifications and reports results. Performs technical review of lab data forms such as water, environmental monitoring and direct measure analysis. Calibrates and maintains lab equipment. Enters final results and raw data for tested materials or products in LIMS (Laboratory Information Management System) as needed.

Responsibilities: Learn techniques spanning across the entire spectrum of analytical chemistry from wet chemistry to HPLC, NMR, Mass Spectrometry, FTIR, GC and GC-MS. Perform testing using a variety of technologies including HPLC, LC-MS, GC, GC/MS, Microscopy, FTIR and UV. Execute projects in support of client needs including product deformulation and product development, failure analysis and problem solving, impurity identification, extractable and leachable studies, and structural characterization. Follow all safety requirements including wearing appropriate personal protective equipment. Generate supporting laboratory documentation. Ensure compliance with government rules and regulations (FDA, cGMP, DEA, ICH, OSHA, etc.). Implement new equipment and processes independently, capable of conducting appropriate qualification and validation activities.

Maintain the APA in accordance with SOPs and within environmental monitoring limits by cleaning and sanitizing all equipment and rooms inside and adjacent to the APA. Document all cleaning and sanitization processes according to SOPs. Perform CIP and SIP processes for Fill Room Equipment. Install and test filters as required. Maintain the APA in orderly conditions by removing culls, performing regular inspections of the equipment and environment and using Aseptic Technique. Prepare and stock process materials for use inside the APA.

Responsibilities: Help to establish protocols around differentiation of primary immune cells, including extensive tissue culture work (maintenance, expansion, and banking). Handling and analyzing workflows pertaining to cellular differentiation and profiling with downstream qRT-PCR, protein quantification, and other molecular readouts. Cloning of constructs to support cellular engineering efforts. Detailed record-keeping and protocol refinement as related to molecular and cellular assays. Facilitate efficient transfer of assays to CRO partners where applicable.

The Document Specialist, Medical Writing will support/assist in the writing, editing, formatting and overall development of clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines.  Clinical regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and clinical sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents.

The RA II will characterize novel therapeutic targets for neurodegenerative diseases and assists in the development of potency assays and phenotypic screens in vitro. Responsibilities: Assist in the characterization of novel diagnostic biomarkers and therapeutic targets for Alzheimer’s and Parkinson’s disease using standard molecular biology techniques. Identification, development, and implementation of cutting-edge methods for characterizing lead biomarker and therapeutic candidates. Contribution to assay development and small molecule screens. Maintain and differentiate several cell lines to support the research efforts of the Neurology department. Report research findings in an organized, clear and timely manner.

This research and development role resides at the interface of several teams across Berkeley Lights, including the software and hardware engineering teams, the chip design and reagents team, and product marketing. In this position, you will have the opportunity to create new capabilities on the Berkeley Lights Platform, taking products from early conception through product launch. Responsibilities: End-to-end workflow development involving precious sample handling, microfluidic-based workflow development, and workflow automation. Validation and verification of complex life science instrumentation. Contribution to the invention of core intellectual property (from conception through validation), white papers, and external publications. This research and development role resides at the interface of several teams across Berkeley Lights, including the software and hardware engineering teams, the chip design and reagents team, and product marketing. In this position, you will have the opportunity to create new capabilities on the Berkeley Lights Platform, taking products from early conception through product launch. Responsibilities: End-to-end workflow development involving precious sample handling, microfluidic-based workflow development, and workflow automation. Validation and verification of complex life science instrumentation. Contribution to the invention of core intellectual property (from conception through validation), white papers, and external publications. 

This position will play an important role in increasing our already extensive catalog of biochemical colorimetric, fluorescent, and luminescent 96-well and 384-well plate assay kits. In addition, this role will assist our analytical services department in establishing additional techniques to expand our service capabilities. This candidate may also be involved in providing technical support to customers.

Responsibilities: Understanding the requirements for study implementation and data collection. Collaborating with project team to develop study-specific edit check criteria. Defining, running, and reviewing edit checks and resolving discrepant data. Maintaining organized, complete, and up-to-date study documentation. Performing study setup, including TF design, database structure, specifications, and obtaining and providing approvals as needed. Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors). Keeping supervisor informed of project status.

Responsibilities: Assist in preparation and reproduction of study materials during study start-up phase of clinical trials. Follow up with outstanding documentations from clinical sites to complete site qualification. Schedule logistical and technical trainings with site personnel. Create test run requests for sites submitting digital data. Review, process, track and monitor all study related data received from sites. Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management. Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors. Investigate and complete logistical edit checks.

Responsibilities: Pickup, receiving and storage of clinical specimens (i.e., blood); accessioning specimens for clinical testing, making labels, setting up tubes and supplies, logging into the computer-based laboratory information system; inventory management support and general lab assistant type work (e.g., maintaining eye wash station, fire extinguishers, shower, stockroom, etc.).

Responsibilities: Perform testing on raw material, in-process, and finished product samples. Execute compendial method verifications, method transfers and validation in support of new product development. Set-up and confirm suitable operation of equipment and instrumentation. Collect data and generate and report results in accordance with governing test methods and SOPs. Work with management in the vent of discrepancies. Perform review of data collected under approved test methods and investigational plans and protocols, in accordance with governing SOPs. Provide accurate assessment of data integrity, and document findings. Work with management and peers to correct deficiencies. Perform calibrations, preventive maintenance, and repairs as needed on instrumentation. Qualify new equipment as assigned.

This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements. Other responsibilities: Perform Packaging Line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and GMPs. Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging. Perform annual retain sample inspections and control finished product and raw material samples stored in the reserve sample room. Perform Complaint writing. Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness.

As a Electrical Engineer you will be responsible for working within the framework of a team and performing the following activities: Schematic design of new and innovative projects. Analyze the hardware and firmware of embedded medical electrical systems with an emphasis on power management, digital and analog controls, and low frequency (500 kHz) high power (500 W) RF amplification. Participate in firmware creation for programmable logic devices such as DSPs, FPGAs, and CPLDs. Participate in hardware and firmware design reviews. Provide design know how for external vendors and supplier development. Support other groups during integration of hardware, firmware, and software. Test and troubleshoot boards and system level electrical systems. Develop, update, and peer-review engineering documents such as instructions, drawings, test procedures and reports.

As a R&D Engineer II, you will use skills related to design and development of medical device components and fixtures as part of a cross-functional team. Responsibilities: Create Solidworks models, drawings and assemblies. Build functional prototypes for device development. Perform engineering testing. Debug via root cause analysis. Investigate new tooling, materials, manufacturing processes and technologies. Research and qualify new suppliers and vendors. Complete documentation of design efforts for the Design History File. Develop, update, and peer-review engineering documents such as instructions, drawings, test procedures, and reports. Collaborate with tooling design teams (MIM, Stamping, Molding, etc.).

As a CNC Machine Operations Engineer, you will use skills related to sustaining and improving production manufacturing processes as part of a cross-functional team. Responsibilities: Develop and sustain manufacturing processes. Debug manufacturing processes and equipment via root cause analysis. Run, observe and expedite shop orders. Develop and update engineering documents such as process maps, process FMEA, Manufacturing/Quality Instructions, test methods, drawings, and test reports. Collaborate with the Production team to identify capabilities and capacity. Collaborate with the Engineering team for fixturing design and development, tolerancing, and design for manufacturing. Collaborate with tooling design teams (MIM, Stamping, Molding, etc.). Investigate new tooling, materials, manufacturing processes, and technologies. Research and qualify new suppliers and vendors.

The Scientist/Sr. Scientist position is within AMT’s analytical development group that is based at Tower Place, South San Francisco. In this role, the scientist will perform method development, qualification, and technology transfer for the release and stability testing of drug substance and drug products. The position will report to Director of Analytical Development and collaborate with cross-functional teams at AMT. Responsibilities: Perform analytical method development for LC based assays such as SEC, IEX and reversed-phase HPLC, and other protein-based analysis (i.e. SDS-PAGE, CE-SDS, A280, etc.). Provide testing support for the in-house manufacture of drug substance and drug product. Execute stability studies to evaluate and characterize protein degradation during storage. Process data and present findings at regular team meetings. Document operating procedures for technology transfer and work to implement methods in a GMP environment.

The Sr. Clinical Data Analyst will be responsible for creating fit-for-purpose analyses, visual data displays and dashboards from diverse data types to aid in internal data consumption and decision-making. This position will report into the Head of Statistical Programming and will interact regularly with diverse stakeholders across the organization. Demonstrated abilities to prioritize work; to understand internal business, data and decision-making needs; and to communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations, safety, medical affairs and commercial) are essential.

This position requires the application of creative problem-solving approaches to the execution of new biochemical and cell-based assays. The successful candidate will have excellent practical laboratory skills, coupled with aptitude and enthusiasm for automated laboratory assay techniques. Responsibilities: Performing routine assays to support chemistry efforts. Execution of new biochemical and cell-based assays. Practical laboratory work, managing day to day tasks and ensuring timely delivery of high-quality results. Utilizing liquid handling systems and laboratory robotics to implement in vitro. Contribute during lab meetings and assist in the analysis and reporting of experimental data to project teams.

The purpose of this position is to transfer product and process knowledge from developmental clinical production to GMP product manufacturing in the drug product manufacturing division of Argonaut. Responsibilities: Facilitate transfer of new processes from client lab or concept to drug product manufacturing by collaborating with subject matter experts and operations management. Participate in client discussions via phone, video conference, and/or onsite visits. Create and revise client-specific batch records, raw material specifications, and any documentation related to Drug Product Manufacturing. Review executed batch records and other documentation, as needed. Track and trend documentation issues.

This job operates in a laboratory environment. Attendance at the office is required. While performing the duties of the job the employee is frequently exposed to various microorganisms and may be exposed to toxic or hazardous chemicals. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, full face respirator and lab coat. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Responsibilities: Media preparation, glassware cleaning, inventory / ordering, lab cleaning and sanitization, and autoclaving various reagents and supplies. Assist laboratory personnel in daily activities to maintain high scientific quality and compliance with SOPs, protocols, and safety standards.

Responsibilities: Adhere to Quality Management System (QMS). Follow prescribed safety rules and regulations in performing all assigned duties. Follow written and oral instruction. Prepare reagents, solutions, and mobile phases required for testing. Perform timely peer review of laboratory notebooks. Sample management including retrieval, storage, and disposal. Work and think independently, yet share ideas and work towards team goals. Use a personal computer including word processing, spreadsheets, email and database applications. Express thoughts in a clear concise manner both orally and written. Work to establish the ability to effectively prioritize and plan multiple work activities with varying deadlines and complexities. Ability to wear, maintain, and properly use appropriate safety equipment, including, but not limited to eye protection, gloves, and lab coat. Adherence to all ARL Bio Pharma safety standards, policies, procedures, and protocols.

The Associate Manager plans, organizes, and controls an assigned product line from conceptual stages through product life cycles to optimize profit and meet marketing, financial, and corporate growth objectives by performing the following duties. Responsibilities: Participates in overall marketing, product strategy, research and development requirements, development, and manufacturing coordination for new and emerging products. Works on technical product development, estimates of potential profits, and release to production. Assists in the management of day-to-day progress and maintenance of products. Provides technical expertise and training to other departments in support of product development. Works with Product Team to develop marketing analysis to determine product definitions.

MeiraGTx is seeking a motivated, enthusiastic, well-rounded individual with experience in molecular biology and biochemistry to be a part of an early pre-clinical stage Molecular and Protein Engineering group to develop better, smarter gene therapies.  For this position, under the guidance of senior scientists, the successful candidate will be primarily responsible for the general laboratory upkeep of the research group and assisting in the construction of mammalian plasmids harboring engineered transgene cassettes, performing transient expressions of said plasmids in relevant mammalian cell lines, and subsequent testing of the expressed transgenes for improved functions using in vitro biochemical and/or cell-based assays.

MeiraGTx is seeking motivated and enthusiastic technicians to join their growing research and development team. The applicant should have experience using standard molecular and cellular biology techniques, will be required to present results and updates at project team meetings, maintain accurate and well-organized experiment records. The qualified candidate will work independently and as part of a team to closely collaborate with other team members. Responsibilities: Maintain cultures of mammalian cell lines. Plasmid DNA extraction and purification, quantification. Perform cell-based assays, high throughput screening. Analyze, interpret and present experimental results accurately, maintain clear and up-to-date experiment records.

The Research Associate - CAR-T Development is an integral member of the Preclinical Immunotherapy Research group. This role will be responsible for the generation and characterization of novel CTL and Chimeric Antigen Receptor (CAR) T cell therapies. The successful candidate will perform experiments to support new product development and IND-enabling activities for Atara’s CAR T cell pipeline. Other responsibilities: Performs retroviral (gamma retrovirus and/or lentiviral) transductions of primary T cells and propagation. Evaluates allogeneic CAR T cell activity, efficacy, and alloreactivity. Performs primary immune cell isolation and multi-parameter immunophenotyping by flow cytometry. Designs and executes assays to evaluate target-specific T cell characteristics and function.

The Associate Scientist will work with the Analytical Development team to develop and execute analytical methods to characterize T cell therapy manufacturing processes and products across the Atara EBV T-cell platform, with an emphasis on flow cytometric methods for characterization and lot release. The candidate will design and execute experiments, organize, document, analyze and interpret results using sound scientific principles. The candidate will present data to cross-functional teams, and thus strong written and verbal communication is essential. 

Atreca is seeking a Research Associate (RA) who will apply her/his skills in cell biology and flow cytometry to screen the growing library of Atreca antibodies for binding against tumor cells. The successful candidate will work in a fast-paced and team-based environment with opportunities to collaborate across different functional groups within the organization. Responsibilities: Harvest and stain cells for screening using flow cytometry in a high throughput format. Flow data analysis and quality control and assay optimization. Follow laboratory safety guidelines and practices.

The successful candidate will play a key role producing and characterizing antibodies and engineered bispecifics in support of pre-clinical studies. This position will have the opportunity to interact and collaborate with a multidisciplinary team and utilize a variety of biophysical techniques to characterize novel therapeutics. Responsibilities: Scout small-scale productions and develop new purification methods to support scale ups of novel therapeutics (antibodies and bispecifics). Produce and purify novel therapeutics at multi-Liter scale for use in pre-clinical studies. Develop and perform analytical methods, including SEC, IEX, HIC, MALS, BLI, SPR, Tm/Tagg and SLS/DLS.

ATUM is in need of an experienced Cell-Line Development Technician to join their team and help lead the development of their growing Cell Line Development Division. You’ll be a key part of the production process and have the opportunity to work with multiple departments in a fun and collaborative work environment. The successful candidate should possess: Excellent hands-on tissue culture experience with HEK and CHO cell-lines. A proven track record in an industrial setting in the development of enhanced mammalian expression platforms through host cell line engineering strategies. Successful experience generating stable cell lines for protein expression. The ability to work collaboratively within and across departments.

This position is under direct supervision of the Group Leader. It is mainly responsible for the manufacturing of plasma products through protein precipitation/separation and other tasks involving plasma receipt, plasma pooling, and protein separation. The Protein Purification Manufacturing Technician will also clean and sanitize equipment before and after use, make and verify connections on flow panels, perform pH and conductivity measurements, performs chemical and buffer additions and may assist Group Leader in training other tech positions.

Responsibilities: Preparing solutions and reagents for performing assays on the bench. Perform Next Generation Sequencing-based genomic assays on different workflows: RNAseq, Whole Genome Sequencing, Whole Exome Sequencing. Carry out genomic assays under Biosafety Level II Policies and in regulatory compliance. Perform Operational Qualification and Performance Qualification on Next Generation Sequencers. Strictly follow standard operating procedures set forth for processing biological specimens while complying with laboratory safety protocols. Strict record keeping of all laboratory procedures. Collaborate within the group and cross departmental to achieve goals.

The Assistant Scientist II is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing.  The Analytical Assistant Scientist II may also assist with method development/method validation projects. Typical types of testing: assays (potencies, related substances, residual solvents, metals etc.), rate of release (dissolution), moisture content, identification, and various other wet chemistry based measurements. HPLC and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include: titrations UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).  The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

The Associate Scientist may be required to work on method development/method validation projects. For this position HPLC and/or GC based methodologies are commonly employed in the described testing.  Other key methodologies applied include: titrations UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company). The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

The Associate Process Validation Scientist supports internal and external Process Validation and Robustness activities with projects focused on understanding and reducing process variability to improve product quality, cost, and process efficiency. This position also supports Cleaning Validation and Facility Environmental Monitoring Qualifications to ensure the production environment is compliant with regulatory requirements. Other responsibilities: Work collaboratively to design, conduct, and report findings on experiments characterizing new or changed manufacturing processes and new equipment or technology. Support continuous improvement projects addressing process variability, efficiency, product cost and data analysis. Compile, maintain and analyze critical data supporting R&D, engineering and validation work. Execute and/or coordinate execution of process, cleaning, shipping and continued process verification activities.

The Metrology Technician will ensure that all equipment is installed, qualified, maintained and calibrated properly, on schedule and complying with any industry or site standards.  This position is responsible for performing a wide variety of activities following site operational and safety procedures in a laboratory and manufacturing setting.  Work will include mechanical service calls, inspections and in-house repairs and preventive maintenance throughout the facility. Other responsibilities: Perform a variety of installation, maintenance, troubleshooting and repair duties on the facility and lab equipment, as assigned. Perform routine calibration, preventive and scheduled maintenance to ensure compliance of the equipment/system for its intended use is maintained and that manufacturing operational requirements are met. Schedule outside venders to preform maintenance and calibration and ensure that tasks are completed on time.

The Associate, Clinical Development is an important member of the Alira Health Clinical team. The Associate will be responsible for facilitation and tracking of all client outreach and will attend client meetings (both in person and remotely). The Associate works closely with the Manager of Clinical Development and will provide administrative support in identifying target clients, potential markets, and tracking related information. As a junior member of the Clinical Development team, the Associate will take on additional tasks as needed, including creation of client-facing materials and presentations and may attend industry conferences as needed. This position includes some travel. Other responsibilities: Assist with the development new business for Alira Health’s regulatory, clinical, and market access practices. Demonstrate an understanding of Alira Health’s range of services, with a focus on regulatory clinical trial, and market access services. Schedule and participate in new client teleconferences and meetings, acting as a facilitator for the senior Clinical Development team members. Track current and past clients, including follow-up, deadlines, and metrics, utilizing Salesforce and other tools.

The Project Coordinator - Distribution supports the Project Manager - Distribution by providing a back-up resource, in addition to managing some accounts themselves. The main objective of the position is to interpret customer supplied information and transform it into instructional documentation for operational distribution staff to complete shipments. The principal function of the project services department is the day-to-day management of all customers across any Almac Clinical Services (ACS) site. Responsibilities: In charge of interpreting customer supplied information, defining requirements, and generating associated documentation to support operational distribution staff in the shipment of finished goods, components, and ancillary items. The Project Coordinator - Distribution will assist the Project Manager - Distribution with all tasks associated with the successful management of the distribution and return of clinical trial supplies. Generate instructions for return, accountability and destruction at Almac facilities and Almac contracted depots.

The QC Inspector Grade 1 – Incoming Goods will Sample, inspect and release incoming goods ensuring compliance with approved material specifications, cGMPs, SOPs, and other written quality standards. Responsibilities: Perform incoming goods sampling, inspection, and approvals in compliance with approved material specification, cGMP and Almac Clinical Services SOPs. Complete calibration checks on balances and scales. Sample clinical materials upon customer request.

Responsibilities: Review and validate clinical trial data. Review case report forms and clinical data sets for errors, discrepancies and protocol violations. Ensure timely completeness and accuracy of databases. Adhere to company procedures related to data handling & data base validation. Implement data entry conventions. Organize and maintain clinical study databases to support regulatory submissions. Design case report forms and related data entry applications. Maintain a thorough understanding of regulatory requirements for data processing operations. Organize and track CRFs, project documents, supplies and enrollments. Participate in project team meetings and recommend processes that lead to timely and successful completion of administrative tasks.

The Proposal Development Associate works as part of the Business Development team by providing support in the development of project proposals, work orders, amendments, and vendor contracts, including budgets for all the preceding. The Associate may participate in sales presentations, client interactions, marketing efforts, and other business development functions. Responsibilities: Support the development of proposals, work orders, and amendments for projects in consultation with Business Development team. Support project budget preparation in consultation with supervisor. Negotiate contracts and budgets with sub-vendors as necessary. Support handoff of new projects to operating team. Maintain client and company experience databases. Provide support to sales and marketing groups as needed. Provide miscellaneous support to the Business Development team as needed.

The Safety Coordinator will assist in data entry of adverse events, reviewing the data and communications such as query generations in Clinical Trials. Responsibilities: Enter incoming data into related tracking systems and databases. Handle incoming data from clinical trial sites. Follow the company and department SOPs and other regulatory guidelines, if required. Write data summary narratives and reports, as needed. Perform data reconciliation for ad hoc and annual reports. Organize, attend and take minutes of meetings. Provide administrative/logistical support. Other duties, as assigned e.g. assist with coding activities.

Responsibilities: Provide training to new employees on cGMP concepts, SOPs, Batch Record execution, Batch record reviews, and Investigations. Basic understanding and knowledge of techniques, instrumentation, and lab functions to identify problems and support the completion of work assignments. Review proposed SOP revisions and provide feedback to management. Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters. Perform room and equipment clearances per procedure following cleaning conducted by production. Data entry to support water, HVAC, and other utilities. Complete additional tasks as assigned by the supervisor.

The Clinical Laboratory Scientist (CLS) is responsible for following all standard operating procedures of the laboratory and adhering to all quality regulations. Additionally, the technologist may be assigned duties by the Lab Manager, Lab Supervisor, and other Clinical Laboratory Operations Leadership for the advancement or maintenance of the laboratory. Other responsibilities: Follow all procedures and protocols pertaining to patient sample processing, pre-analytical, analytical, and post-analytical testing and general laboratory system that do not directly involve the manipulation of patient samples or products generated from patient samples of assigned assays (typically 1-2 methodologies). Adhere to all Quality regulations (CAP, CLIA & New York State) and ensure all training and competency forms are complete. Daily processing of patient samples within assigned workflow or assay. This includes generating work lists, plate maps, pulling and filing of primers and reagents daily, pulling and filing of patient samples daily and accurately processing of samples within assigned workflow or assay within specified TAT’s. Timely and accurate completion and update of sample processing paperwork and lists on a daily basis either manually or electronically making sure to note any abnormal issues.

Amicus is seeking an Associate Scientist to join the Bioanalytical team and perform LC-MS/MS method development and study sample analysis to advance Amicus projects and programs. Responsibilities: Performing routine analysis for the quantification of small-molecule drugs, lipids, biomarkers and peptides in biological samples using defined LC-MS/MS methods. Processing and evaluating analytical data obtained from LC-MS/MS analysis of study samples using appropriate software. Reporting results of the study sample analysis, prepare study associated documentation, and maintain an electronic laboratory notebook. Developing novel LC-MS/MS methods for the quantification and/or characterization of proteins and biomarkers of disease.

The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Other responsibilities: Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).

The Quality Systems Coordinator leads and reports data generation, data analysis and data interpretation. Create summary findings to support investigations, Corrective and Preventive Action (CAPAs), complaints etc. Monitors short-term and long-term effectiveness checks and monitors quality assurance trends related to Quality Management System (QMS) processes. Responsibilities: The QA coordinator will work collaboratively with users of quality system software on the collecting and distribution of reports related with quality documents. This includes coordinating and facilitating all aspects of planning, evaluation and reporting, problem resolution and solution to any quality issue. Performs evaluation of Change Controls in accordance with established procedures and ensures close out of these documents. Provides Quality Assurance (QA) management with timely data analysis and insights for potential corrective actions and improvements; and works collaboratively with QMS process owners, QA management and stakeholders to support quality improvement and data collection and organization.

The Scientist-2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment. Responsibilities: Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. Develops and optimizes new and existing analytical methods for qualification and release testing of products. Develops stability indicating methods and performs methods validation. Provides timely responses to all internal and external inquiries.

The Lab Tech is responsible for supporting routine operations of the Fermentation and Purification Labs and completing routine laboratory procedures under the direction of the BioProcess Development and Manufacturing Lead. Other responsibilities: Conduct routine lab procedures (preparation of media and solutions, calibration of and testing with pH and conductivity probes, endotoxin testing, and good record keeping throughout). Weigh and mix specified components in calculated amounts, recording throughout. Set up and operate necessary equipment to support the above. Collaborate with manager, team members, and other functional groups at Amunix to plan, prioritize, and meet delivery deadlines.

The PCB Layout Engineer will be working within a team environment to design and draft complex electronic PCB’s layouts and drawings. The qualified individual must be able to work in a fast-paced team environment and be responsible for schedules and deadlines. Responsibilities: Create footprints per supplier datasheets and IPC standards. Maintain and support Abbott eCAD Library. Layout of complex mixed-signal, mixed technology, high-density PCB designs. Provide full documentation for fabrication and assembly. Understanding pin mapping assignments in complex part symbols. Layout for placement and circuitry routing of PCBs for optimal electrical, EMI, thermal, and structural performance.  Understanding of design rules constraint management and parasitic analysis. Use 3rd party tools to perform Design Rule Checks and insertion of test probes. Interface with Vendors and Suppliers to import and export data for fabrication of bare boards and installation of electronic and mechanical components.

Abbott Diagnostics has an opening for a Research Scientist. This qualified and motivated scientist will join a dynamic R&D team developing novel methodologies and assays for next generation diagnostic applications. These activities may also support the development of next generation instrumentation. This individual will help conceive, plan, design, and conduct advanced studies. The Research Scientist will investigate and develop new procedures. He or she will act as an independent contributor and will interact/coordinate with other groups and functions on project development and improvement. The successful candidate must have strong analytical and quantitative skills, as well as excellent oral and written communication skills.

The scientist will lead and consult on multiple complex projects defined for process investigations; design changes; resolving production issues and improving product availability and profitability. Leads a cross functional team with the required product/process knowledge to assess impact and develop plan. Focus will be in protein purification with one or more of fermentation, cell culture or recombinant protein experience. Other responsibilities: Demonstrate an understanding of the application of the Quality Policy through daily activities. Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management. Develop and apply operations and process knowledge to area of support. Use sound judgment; appropriate scientific methods and thorough data analysis. Conceive; plan; design; execute; and document projects/activities efficiently and in conformance with applicable OPs.

As a member of the clinical support team, you'll be responsible for providing technical clinical expertise and support of the sales process to colleagues, current customers and/or potential customers. Other responsibilities: Works under general direction with clinical and sales teammates to identify and capitalize on sales opportunities by creating competency, comfort and expertise with all Abbott Chronic Pain Therapies among physicians, support staff and customers within assigned geography. Performs work that involves a high degree of independence. Exercises independent judgment in planning, organizing, and performing work. Seeks to continually improve territory efficiency. Will begin to conduct PCP work and educational in services, as directed. Provides medical professionals with sales support, information, and training on the use of Company products and with staff education, in-services and technical troubleshooting.

The Quality Control Technician II will be responsible for, but not limited to, performing inspections following procedures, specifications and applicable standards and regulations. Providing technical support to cross-functional teams as needed, identifies potential discrepancies and nonconformance and alert management. Performing porcine and human tissue receipt, and inspection, in-process inspections i.e. e-beam), and performing product discard as per procedures in an electronic data system.  Ensuring proper equipment functionality and appropriate levels of supplies. Supporting and partnering with cross-functional teams to resolve any issues or non-conformance encountered. Assisting in documentation updates and related change controls activities as needed. Perform ing applicable actions for Nonconformance Reports (NCRs), Supplier Issues (SIs), Engineering Change Orders (ECOs), etc.

The candidate will have a critical role in supporting the overall Aesthetics Biological Research Program by managing inventory, administration of personnel training, and management of personnel security access. He/she will be the team Subject Matter Expert regarding a custom inventory database as well as policies and procedures for registration, use, shipment, and receipt of inventory.  The candidate will coordinate and oversee inventory audits and will represent the team in interactions with EH&S and both internal and external auditing agencies. The candidate will identify and recommend changes in policies, procedures, and software design. He/She will coordinate shipment and receipt of samples, including entry of inventory into the electronic inventory system.  Responsibilities will also include management of a freezer monitoring system. The candidate will also utilize a learning management system to administer and track personnel training on required SOPs.  He/She will complete, submit, and manage security access requests for secured lab areas. In addition to the Biologic inventory responsibilities, the candidate will also support the team with protein quantification, SDS-PAGE, Western blot, and additional protein and DNA analysis, including documentation of results. Candidate will also partner with Departmental Lab Operations staff to escort vendors and service technicians during on-site visits into research labs.

This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally. Responsibilities: Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources. Analyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources with supervision. Utilizes medical judgment to determine the impact of identified safety issues on the compound/ product’s benefit-risk profile. Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes. Responsible for standard surveillance activities for a product’s life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature.

Abeona is looking for an Upstream Process Development Associate to join their team in Cleveland, OH. The successful candidate will be responsible for to support upstream process development initiatives and will be an integral part of a fast-paced group responsible for developing production processes for the manufacture of clinical AAV gene therapies. Responsibilities will include executing experiments across multiple scales from small shake flask cultures up to 200 L bioreactors. The ideal candidate will have some experience in production of biologics in either a research or development setting. Conducting research involving biochemical assays, effectively communicating results through high quality technical reports and oral presentations, and collaboration with your team is an integral part of this position.

The Research Associate will be primarily occupied with executing a variety of high throughput assays. These include flow cytometry and cell sorting, ELISA, and plate based micro-fermentations. This position will be responsible for independently preparing media and buffers, processing samples, and preliminary analysis of results. Work will be done on a variety of automated hardware platforms including flow cytometers and liquid handlers. Candidate is enthusiastic about laboratory bench work, exhibits meticulous attention to detail, an eagerness to learn new techniques, and is comfortable working in a highly dynamic and rapidly scaling company. Responsibilities: Prepare needed buffers, stock solutions, and media. Independently execute strain screening experiments. Compile and enter data into the company’s LIMS system. Preliminary analysis of data to ensure operational integrity before handoffs to downstream groups.

In this role you will perform chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with cGMP, ACC SOPs, and FDA Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

AccuraGen is developing systems that will provide the most sensitive, accurate, and robust NGS-based ctDNA mutation detection. It will deliver unparalleled accuracy from a minimal amount of patient blood samples. They are looking for an outstanding individual to join their R&D team to drive technology innovation, product development and commercialization. Responsibilities: Plan, design and execute assay research and development experiments. Analyze data, evaluate results, form conclusions, and provide and/or implement improvements. Communicate results with colleagues and R&D management. Ensure product performance by utilizing proven development practices and/or developing novel procedures to overcome obstacles. Optimize and document SOPs to achieve commercial levels of stability, robustness and performance.

The Clinical Research Analyst is responsible for assisting research institutions with budget development and negotiation, coverage analysis, and clinical trial management system services. The Clinical Research Analyst will complete these critical functions in a manner designed to expedite the conclusion of the start-up process for our clients while maintaining a high level of quality. They are in need of critical thinkers to help interpret Medicare/Medicaid guidelines, analyze clinical research protocols, and work directly with our clients to develop and negotiate clinical trial budgets. Responsibilities: Interpret Medicare/Medicaid coverage decisions and national guidelines to determine what procedures are billed to the sponsor and which are billed to Medicare/private insurance. Identify appropriate research modifiers to be placed on claims. Develop and negotiate clinical trial budgets based on client’s preferred pricing methodologies. Build studies within client’s clinical trial management system (CTMS). Work with Senior Clinical Research Analysts and Manager to review and alter deliverables as needed.

The Quality Control Associate will be responsible for conducting in-process and finished product testing associated with Adaptimmune clinical trial material. In addition, the role will be working with other departments for deviations and method transfers. Responsibilities: In-process, finished product and stability testing of clinical trial material. Maintenance of Quality Control Protocols, SOP’s and Test Methods. Deviations, change controls, CAPAs. Method / Technology Transfer of existing methods into the Adaptimmune QC Lab

The Accessioning Specialist II position will join the Biological Sample Management (BSM) group at Adaptive Biotechnology’s Seattle laboratory. The primary function of this role is to support sample management and chain of custody for Adaptive’s immunosequencing services that includes research, clinical projects, and diagnostic testing. Responsibilities: Enter, upload and ensure accuracy and completeness of information pertaining to samples and related projects through multiple systems. Ensure there is a record of every system transaction relating to each managed sample in order to evidence sample Chain of Custody (COC). Ensure appropriate inventory management (freezer management) of each physical sample through the entire sample management lifecycle.

This position is responsible for developing software processes to ensure that software development practices comply with applicable regulatory requirements, as well as supporting day to day quality operations and processes supporting software engineering efforts at Adaptive. This position is accountable for ensuring that the Adaptive SDLC is both efficient as well as compliant with applicable international (IVDD/IVDR), Federal (21CFR), and other applicable regulations.  In addition, this position is responsible for maintaining quality processes such as assisting in Nonconformance and CA/PA investigations and actions. The position requires the ability to manage priorities from multiple projects and tasks utilizing effective written and oral communication skills. Will apply quality and regulatory systems knowledge, problem solving and judgment skills to ensure the appropriate balance of quality, compliance and business needs.

Responsibilities: Understand the cGMPs and processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}). Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures. Review and release manufacturing batch records, and any additional supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data. Perform usage decisions for batch release in SAP. Work with IgG Manufacturing floor personnel and other technical operation departments to resolve documentation and compliance issues. Perform period follow-up of ongoing deviations to assure timely closure of documentation and batch release. Review and approve Certificates of Analysis for batch release in LIMS. Review SOPs and documents from other departments and provide feedback as necessary. Perform review and release of Plasma pools when required.

This position is responsible for performing protocol-defined bioassays on proteins and antibodies to demonstrate the activity of a product.  The position requires maintenance of cell lines and isolation of primary cells for use in the assays.  Good Manufacturing Practice (GMP) documentation and workflow is required in this position.  Participate in troubleshooting as needed. Responsibilities: perform routine bioassays following the instructions for quality control on proteins, antibodies, and related products, perform more complex bioassays following the instructions for quality control on proteins, antibodies, and related products, analyze and report data with the consideration of intra and inter-assay variations and other factors which may affect the assay results, keep accurate records of all experiments performed, follow GMP guidelines, documentation, and workflow, maintain cell lines; isolate primary cells from human/animal blood and animal tissue for use in bioassays, freeze cell stock for future applications. 

The research associate will work within a highly dynamic group and be responsible for developing new products and applications for RNAscope technology. Responsibilities: Execute RNAscope/BaseScope-based assays to support new product development and assay optimization, including but not limited to BaseScope manual assay testing, R&D collaboration projects and RUO raw material improvement projects. Support manufacturing QC for commercial product testing, release and troubleshooting when needed. Facilitate SOP/SPK/SPJ drafting/assay QC procedure transfer from R&D to QC team. Participate in R&D/QC communication and hands-on training. Responsible for experimental design, assay running, data collection and interpretation.

They are seeking a protein biochemist who will contribute to the ongoing research and development of products including complex assay systems, post-translationally modified proteins and peptides, and recombinant enzymes. The candidate will have previously purified proteins from bacterial, insect, and/or mammalian expression systems, and will have theoretical knowledge or hands-on experience with isolation of proteins from prokaryotic and eukaryotic organisms. Responsibilities: carry out troubleshooting activities under supervision, collaborate with other departments/labs as needed, follow guidelines and comply with all company safety, quality, and training procedures and regulations.

They seek a highly motivated and creative Research Associate to join the R&D team. You will work within a highly dynamic group and be responsible for developing new applications for RNAscope technology and support our assay services business. Responsibilities: Execute Custom Assay Services (CAD)/PAS projects, including but not limited to ISH-IHC, pre-project proof of concept/probe validation, troubleshooting and others. Focus will be ISH-IHC and new application development to support ISH business expansion and accumulate more in-house experience for new technology development. Responsible for experimental design, assay running, data collection and interpretation.

Advanced Quality Technician reports to the Quality Control Manager and is responsible for in-process and final QC testing of Bionostics products.  In addition, Advanced Quality Technician participates in instrument validations, performs lab maintenance activities, initiates collaborations, monitors laboratory and process inventories, conducts device history record review, and creates certificates of analysis for commercial products. Responsibilities: Understands and adheres to all quality technician job requirements. Follows work instructions carefully and demonstrates good documentation practices. Documents results, processes testing, and refers to past batch records when needed. Compiles, analyzes and reports on data conformity

The laboratory technologist will support contract research offerings as part of Ultivue’s Assay Development and Services Laboratory. Laboratory work utilizes Ultivue’s InSituPlex™ technology for fluorescence multiplex IHC (mIHC). The lab technician will support routine testing and QC procedures. Technician may take part in basic assay optimization and multiplex panel development activities to support services and U-VUE kits offerings. Responsibilities: Follow laboratory protocols and safety regulations in accordance to a quality management system (QMS). Edit SOPs in continued effort towards regulatory compliance. Perform routine logging of specimens and documentation of sample testing into Ultivue’s laboratory management information system (LIMS). Perform related laboratory maintenance, such as ordering supplies, managing inventory, managing and maintaining equipment, and documenting laboratory conditions. Perform routine and testing of InSituPlex™ assay utilizing specific standard operating procedures (SOPs). Assist pathologist and Ultivue scientific staff in imaging and test support.

QC Analyst I is responsible for performing drug substance and drug product in-process, release, and stability testing activities in support of CGMP manufacturing of clinical trial materials. This candidate will also be responsible for providing support to R&D for analytical development and other activities as assigned by supervisor. Other responsibilities: Provides QC support to development and manufacturing in the form of CGMP assay support involving release and stability testing. Performs product characterization activities, including:  potency assays, drug product physical characterization, and stability assessment. Performs work necessary to implement procedures appropriate for analysis of drug substance and drug product clinical trial and development materials. Maintains the QC laboratory.

The incumbent will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies. This position includes hands-on participation, including materials logistics, assisting in manufacturing operations, and may include non-routine development activities. This is a full-time position. Requirements: Assist in manufacturing operations to produce GMP grade PEC-01 and Combination Product to meet corporate goals. Assist in ensuring that there are sufficient materials available for all production runs or campaigns, including media, small molecules, and growth factors. Provide hands-on support for scale-up and development activities as needed based on a demand plan. Understand and review applicable GMP documentation, including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents. Maintain current training status for all applicable activities. Assist in maintaining GMP areas in a constant state of inspection readiness related to equipment and area preventive maintenance, calibration, and certification. Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions, and comply with regulatory requirements.

The Tissue Processing Technician I supports the Tissue Processing Supervisor in the cleaning, cutting, shaping, inspecting, and packaging of tissues for transplantation. The Tissue Processing Technician I is also responsible for complying with the quality assurance requirements and quality system goals of the bank as mandated by federal, state, and trade regulations. Other responsibilities: Preparation of clean room and clean room procedures as specifically described in SOPs. Preparation of aseptic processing, environmental set-up including all equipment supplies and monitoring of sterile rooms. Processing of all allografts for clinical such as bone, soft tissues, skin, autografts and other tissues as instructed by Processing Supervisor or designee. Preparation and preservation of all types of bone for cutting and shaping into allografts.

Responsible for the delivery of superior customer service through the use of effective communication and coordination in the receipt, processing, and placement of allograft tissue orders from customers and/or distributors of the tissue bank. Handling allograft orders demands a great deal of attention, detail orientation, and management of time to ensure that allografts reach the desired destination. Builds and maintains business relationships with clients by providing prompt and accurate service to promote customer loyalty to Vivex Biologics, Inc. Other responsibilities: Serves as the first point of contact for general inquiries such as pricing, product availability, and allograft-related technical questions. Ability to identify customer needs and offer product substitutions based on surgical procedures or historical data. Responsible for initiating calls to existing and potential customers to generate revenue for direct distribution. Coordinates the demands and needs of international distribution commitments of the tissue bank to include, tissue allocation, request for tissue production, shipping/customs documentation, and certificate of conformance (if applicable).

The QA Specialist is responsible for performing Quality compliance activities on the plant floor and ensuring that all activities are in compliance with company and regulatory guidelines and procedures.  In addition, the QA Specialist is also responsible for assisting in activities directly related to batch release, and batch record and procedure review, revision and approval.  The QA Specialist is required to consult with the Quality Management on all serious issues that may impact the company or product.  

The Medical Affairs Specialist collaborates with members of cross-functional teams to prepare high-quality correspondence, study protocols, investigator brochures, synopses, regulatory documents, medical and clinical publications, and related medical and clinical documents within agreed-upon timelines. Responsibilities: Prepares, edits, and finalizes protocols, medical affairs scientific presentations, abstracts, manuscripts, and correspondence. Participates in scientific communication planning, including development of strategic medical communication plans, publications in Medical and Scientific Journals, online webinar content creation. Supports the writing, review, and edit of Marketing and Medical Affairs/Clinical Development materials. Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents. Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.

This is a unique cross-disciplinary position that will work closely with a variety of groups including Molecular Biology, Chemistry, Microfluidics, QC, and Manufacturing, to develop and validate novel reagents for the rapid expansion of 10x product lines. Candidates must have a broad working knowledge of molecular biology and be able to apply that knowledge creatively and independently in a fast-paced work environment. The successful applicant will have exceptional attention to detail and the ability to meticulously execute and analyze highly complex experiments. Previous industry experience is essential.

Responsibilities: Executing high throughput screening (HTS) assays in strict accordance with the NIH NCATS Assay Guidance Manual. Developing and validating HTS biochemical assays for characterizing the activity and selectivity of potential drug candidates. Developing and validating HTS cell-based assays for characterizing the activity, selectivity, and cellular permeability of potential drug candidates. Performing a wide variety of experiments across molecular biology, cell biology, biochemistry, in vitro pharmacology, and in vivo pharmacology. Rigorously documenting all experimental procedures, data, results, manuals, etc. in an electronic laboratory notebook (eLN). Leveraging internal and external personnel to troubleshoot experiments. Effectively communicating research results both verbally and orally. Managing all external CRO relationships and cross-checking externally generated results with internal references and/or expectations. Managing all aspects of lab operations such as ordering, organizing, and restocking reagents, equipment, and other supplies.

The ideal candidate will have experience in animal handling and basic research techniques such as sample collection and data recording. As a Study Coordinator, you will help in all these areas, as well as overseeing the daily data collection and study conduct of our animal technicians and junior veterinary staff. It will be your responsibility to ensure they have a clear understanding of study protocol and activities. You will assist in planning out the study timeline, ordering supplies, developing forms, and managing pre-study meetings under the direction of a Study Director. You will be in a strategic role helping not only oversee studies for senior research staff, but communicating with our clients, other departments, and helping teach our animal technicians proper procedure and study conduct.

The Engineer I/II (EIT) supports development of medical device products with work including writing or verifying specifications, designing new products, fixtures, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Typical job duties might include developing new product concepts and products, engineering design and process development, generating intellectual property and writing invention disclosures, supervising assemblers, technicians, and specialists, and largely self-directed, capable of meeting project goals with moderate supervision. This 24-month rotational program is designed to train new Engineers on various aspects of MicroVention - Terumo technology, procedures, and processes.

Sorrento is currently seeking a Manufacturing Associate who will be responsible for performing Upstream manufacturing tasks including tracking and control of raw material inventory; maintenance and operation of equipment in cGMP facilities; preparation of buffer and media; and assistance in operation of single use bioreactors for production of clinical and commercial products. Responsibilities: control and track raw material inventory, maintain and clean cleanroom facility and equipment, perform daily monitoring of equipment and assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration, prepare media and buffer solutions, maintain cell culture flasks using good aseptic technique, assist in the operation of Single-Use Bioreactors, including the Wave Cellbag bioreactors and HyPerforma 100L, 500L, and 2000L systems.

The QA Specialist’s responsibilities are divided into three primary functional areas: Raw Material Inspection and Release, Label Generation, and Document Control. Raw Material Inspection: Associate is responsible for inspecting in-coming raw materials, releasing raw materials, obtaining and submitting test samples to the appropriate contract laboratory, and coordination of receipt of test results. Label Generation: Associate is responsible for ordering label and ribbon stock, generating Master Label templates from approved label specifications, producing labels for specific product lots, ensuring labels are verified as correct and are released in time to meeting the manufacturing schedule. Document Control: Associate is responsible for document control system, including but not limited to change control, word processing, training and equipment database, and maintenance of documents and document site; in addition, the associate shall assist with investigations as directed by QA Management; assist in the execution of validations, or other duties assigned by the head of QA.

Responsibilities: execution of cell-based assays to support characterization and development of lead candidates, aid in mechanistic and target validation studies using ELISA, SDS-PAGE, Western Blot, and flow cytometry, maintaining various cell lines for cell-based assays, assist in mAb/conjugate purification and buffer exchange, partake in instruments’ maintenance and calibration, lab cleanliness and orderliness, as well as ordering and replenishing stocks, analyze data and interpret results, keep clear and accurate records for both laboratory notebook and reports.

The Upstream Antibody Process Development & Manufacturing team is currently seeking an Upstream Associate who will be responsible for performing Upstream process development and manufacturing tasks including cell culture, cell banking, media preparation, benchtop bioreactor operation, and assistance in single use bioreactors operation for production of clinical and commercial products. Responsibilities: assist in the operation of Single-Use Bioreactors, including the Wave Cellbag bioreactors and HyPerforma 100L, 500L, and 2000L systems, review and revise current Good Manufacturing Practice (cGMP), Batch Production Records, SOPs, protocols, and reports, provide support to cross-functional teams to meet production or timeline demands, demonstrate understanding in technical operations, safety, and cGMP, ensure the completeness and accuracy of manufacturing documentation per approved procedures.

Responsibilities: Provide direction on the Facility and Process Requirements (Both Upstream and Downstream) for new and existing facilities.  Be the key point of contact between engineering design firms and internal Spark Manufacturing and MS&T resources.  Evaluate conceptual aspects of technical process designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.  Develop relationships with Roche Engineering resources and leverage existing facility and process designs, requirements documentation, and equipment vendor relationships and other design documentation from Roche. Ensure plans are created and updated in a timely manner, communicated to relevant stakeholders, assess risks, and manage deliverables. Meet scheduled milestones to ensure project/program objectives are met in a timely manner. Use rapid design principles in accordance to Corporate Standards.

The Manufacturing Science and Technology (MST) Upstream Process Scientist/Engineer is an entry-level position within the MST Lab team, which is responsible for carrying out laboratory experiments to support clinical and commercial manufacturing of gene therapy products and late-stage process development activities.  To support manufacturing, the incumbent will develop an understanding of Spark manufacturing processes in order to assist in the evaluation of raw materials and equipment, investigation of process deviations and development of process improvements. Late-stage process development activities, such as process characterization, will require the incumbent to build an understanding of new processes in the clinical pipeline delivered from the Process Development organization, with whom the incumbent will interact with regularly. The incumbent’s major responsibility in the activities described above is hands-on execution of laboratory experiments for upstream bioprocessing, such as cell culture in flasks and bioreactors. The experimental scope spans experimental design, in-lab execution, documentation of results using Good Documentation Practices and data analysis. The incumbent will also take part in the tech transfer of production processes into clinical and commercial manufacturing suites through interaction with the Process Development organization and both internal and external manufacturing partners.

This role supports the execution and analysis of experiments and data through technical execution and by supporting experiment planning and organization. This role meticulously documents experiments and their outcomes which helps support potential regulatory filings. Responsibilities: Meticulously execute bench work, analyze data, troubleshoot, and communicate findings; perform in vitro assays using multi-color flow cytometry, ELISA/ELISPOT, and cellular biology methods as well as in vivo studies using murine disease models; optimization of new assays with minimal oversight and analysis of data; gather and critically analyze and experimental data to shape decisions around the direction of studies; deliver biomolecules to cells using the SQZ device; support quality control and review of Investigational New Drug (IND) filings and packages; manage large data sets and compiling data for analysis; contribute to experimental design and project direction in support of team goals.

This position works closely with a scientist to design and execute experiments aimed at pre-clinical validation of new cancer treatments. Responsibilities: perform in vivo studies using murine disease models; bench work, analyze data, troubleshoot, and communicate findings; perform in vitro assays using multi-color flow cytometry, ELISA/ELISPOT, and cellular biology methods; optimization of new assays; manage large data sets and help with data visualization; work split between solo and team work, executing on multiple projects simultaneously; possess excellent organizational skills and “can-do” attitude and ability to shift focus based on multiple priorities and deadlines.

The candidate will support process development efforts for our clinical and pipeline cell therapy products. Responsibilities: Perform hands-on laboratory work using SQZ proprietary equipment and data analysis; maintain electronic lab notebook, study plans, and experiment reports; support across different functional teams to ensure successful completion of necessary studies; support troubleshooting and identification of corrective actions during the execution of laboratory experiments; adhere to safe laboratory practices; prepare experimental summary presentations to process development team and management; perform data analysis and statistical trending on in-house lab experiments.

Responsibilities include creating & implementing labels for OTC & ANDA submissions, assisting in ANDA submissions using eCTD submission software, preparing & maintaining annual reports, SOP, deviations & OOS reports, and reviewing product complaints & queries & support in developing regulatory strategies & launch OTC products.

Responsibilities: Performs protein titer determination of fermentation pellets and in-process samples using HPLC and mass spectrometry. Executes SEC, IEX and RP-purity assays following SOPs for product characterization. Performs protein and peptide detection assays using qualitative and quantitative techniques including UV/Vis, SDS-PAGE, and western blot. Assists in troubleshooting and maintaining modern analytical instrumentation. Executes experiments, conducts analysis and reports results. Maintains Standard Operation Protocols (SOPs) and reference materials. Manage and maintain required reagents, laboratory environment, and equipment needed to carry out assignments. Assists research team in protein and peptide purification and prepares samples for mass spectrometry analysis. Prepares research reports and presentations for team meetings. Works closely with team leaders to complete highest priority work to reach goals and milestones.

The candidate will support senior management in enabling all facets of drug and vaccine development, including data management and analysis, as well as the creation of documentation supporting regulatory submissions, applications and final reports. The candidate will also possess the ability to work within a fast-paced multidisciplinary environment to drive the development, implementation and maintenance of software and hardware tools to support and track multiple projects simultaneously. Responsibilities: Work with research and development scientists, in-house, as well as with representatives of diverse CROs and other service providers in multifaceted support of drug and vaccine development; this will include quality control and analysis of internal and external data sets, generation of reports, regulatory documents, etc., as well as the creation and operation of related software and hardware tools. Work closely with in-house and outsourced expertise to add statistical rigor and quality control to analyses and provide concise summaries of key experiments. Bring strong attention to detail to the team along with skills / aptitudes in developing data processing, analysis and communication tools.

Translate Bio is seeking a highly motivated and scientifically rigorous individual to join the Delivery and Formulation Development team as a Research Associate. The position will focus on stability evaluation of frozen and lyophilized drug products. Responsibilities: Conduct experiments for advancing understanding of stability of lipid nanoparticles (LNP) drug products and provide storage and shipping conditions aligned with success administration of drug product for preclinical and clinical studies. Perform experiments to establish stability parameters, improving physical and chemical stability and integrity of drug product upon long term storage. Support drafting new and revising existing stability protocols for long term stability of drug product. Contribute in writing/reviewing analytical method protocols/stability protocols. Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams.

Translate Bio is seeking a highly motivated and scientifically rigorous candidate to lead from the bench as an Associate Scientist/Senior Research Associate in the RNA Sciences Team. The position will focus on plasmid synthesis, DNA characterization and supporting the Translate Bio programs and collaborations. The position will be highly collaborative and give the successful candidate a broad range of experience across functions within the organization. Responsibilities: Synthesis, purification, and characterization of plasmid DNA. Support high throughput plasmid synthesis and purification efforts. Support platform projects by performing assays including capillary & gel electrophoresis. Independently design and execute decision-quality research. Prepare technical reports, presentations, and recommendations to management and other stakeholders.

The Associate Engineer reports to the Senior Engineer and is an integral part of CPD&P team. This position offers opportunities to focus on drug substance and drug product process development, manufacturing, regulatory and analytical support, validation, and data review for drug substances and drug products. The Associate Engineer is responsible for assisting in the development and execution of scalable and robust processes for drug substance and drug product. This position will assist the CPD&P Subject Matter Expert (SME) for process knowledge transfer for drug substance and drug product to support cGMP manufacturing.

The Quality Technician role is established to support the Simple Plex Consumables team in the Wallingford facility. Assists Quality Analysts and the QA team in our ISO compliant environment.  Provides support for QC / QA activities including hands-on evaluation of microfluidic cartridge products. Responsibilities: Adherence to safety procedures and compliance with department specific SOP’s. Understanding of quality body of knowledge, standard laboratory procedures, and record keeping guidelines.

This hands-on position will support development and troubleshooting of novel polymeric reagents for cell activation, cell separation and other CGT applications. As part of the R&D team, this role will support product development by formulating reagents and testing them in a variety of analytical and cell-based assays. The role will work closely with product teams to develop new products and troubleshoot production of existing products for research and clinical applications. Responsibilities: Characterize hydrogel microparticles via ELISA, microscopy and flow cytometry based assays using established protocols in support of product development and manufacturing efforts. Generate test batches of proprietary hydrogel microparticles using laboratory equipment and functionalize product prototypes with proteins using bioconjugation protocols. Conduct cell-based experiments to evaluate functionality of product prototypes on immune cells. With supervision design, execute and interpret experiments to meet R&D objectives. Collaborate with a diverse team of biologist, chemists and engineers to develop new products for cell and gene therapy applications.

The Manufacturing Operator I performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput and quality. Learns, understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties. etc.

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. RESPONSIBILITIES: Coordinate with internal team to conduct general laboratory work, including liquid formulation batching, wet chemistry and instrumental analysis using specialized lab equipment. Maintain accurate and complete records of testing results and report results to manufacturing and engineering teams. Prioritize workload and departmental needs to a test schedule to meet individual and company deadlines. Maintain all laboratory equipment according to GMP, GLP, and 5S standard; ensure lab meets organization needs for accurate and sustainable test practices. etc.

Essential Functions & Responsibilities: Repair relief valves, control valves, on/off valves and pneumatic actuators in FCX actuation facility or customer plant locations. Mechanically and electrically troubleshoot, inspect, and test valves at specified job worksites. Primary worksites include FCX valve repair centers with occasional customer in-field work sites. Perform pre-testing, disassembly, cleaning, in process inspection, machining, lapping, painting, assembly, testing, and final inspection on various types of valves and actuation. Perform testing on certified test equipment, and complete all documentation by working under a QA / QC / National Board VR program. Complete field service worksheets and submit to job coordinator upon completion of work. Understanding of pneumatic and digital controls. Ability and knowledge to reference appropriate valve manuals for repair requirements. etc.

Completes calibrations and qualifications in a safe, timely, and accurate manner, following PCI and client specific policies and proposals. Responsible for proper handling and maintenance of PCI and client equipment, including testing and standards equipment. Identifies project supply and equipment needs and conveys to the appropriate resource to ensure availability. Works to understand client needs and requirements through effective communication and develops client relationships through excellent customer service. Ensures client requests are conveyed to the appropriate PCI management resource and met in accordance with management direction. etc.

Completes calibrations and qualifications in a safe, timely, and accurate manner, following PCI and client specific policies and proposals. Responsible for proper handling and maintenance of PCI and client equipment, including testing and standards equipment. Identifies project supply and equipment needs and conveys to the appropriate resource to ensure availability. Works to understand client needs and requirements through effective communication and develops client relationships through excellent customer service. Ensures client requests are conveyed to the appropriate PCI management resource and met in accordance with management direction. etc.

Pipette Technicians are expected to take a proactive role in supporting the Pipette Services Team and in providing client pipette support. The Pipette Technician is expected to build a high level of trust with internal and client personnel. This trust is developed through consistently upholding PCI Values and demonstrating Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment. Responsibilities/ Assignments: Works with basic laboratory instrumentation, as well as operates computer-based applications utilized in a laboratory environment. Further develops technical skill whenever possible through internal or external training programs. Completes calibrations, qualifications, PMs and changes with GxP documentation in an accurate and timely manner and in accordance with PCI and Client Standard Operating Procedures (SOPs). Always considers safety when executing tasks and projects. Ensures that PCI work areas are safe, neatly organized and professional on-site and in office. etc.

Osprey Biotechnics is a worldwide leader in the development of bioproducts for a large range of bioremediation and bioaugmentation applications including wastewater, soil/ground water, industrial and consumer products, poultry, and agriculture. We are seeking enthusiastic, team-oriented individuals to join our down-stream processing group in this full-time, entry-level position. This position is 2nd shift, Monday through Friday from 12pm - 8:30pm, with some weekend work and OT potential. Key Responsibilities: Retrieving materials to spray dry. Operating spray drier and monitoring its automated operation. Recording temperature readings throughout the operation and verifying the chart recording. etc.

Osprey Biotechnics is a worldwide leader in the development of bioproducts for a large range of bioremediation and bioaugmentation applications including wastewater, soil/ground water, industrial and consumer products, poultry, and agriculture. We are seeking enthusiastic, team-oriented individuals to join our blending department in this full-time, entry-level position. This position is 1st shift, Monday through Friday from 7:00am - 3:30pm, with occasional weekend work and OT potential. Key Responsibilities: Able to perform repetitive blending and line bottling operations. Stand for long periods of time. Basic arithmetic skills such as adding, subtracting, and measuring volume/weight. etc.

The Research Associate I or II, CMC-Analytical – Cell Biology, will work in the Cell Therapy Bioassay/Immunoassay/Flow Cytometry group of Precision BioSciences. This individual will provide biologic analytical support for Product Sciences and Cell Therapy Process Development projects. The position will contribute to development efforts for CART-cell projects by providing sample preparation and analysis in a timely manner. This position is lab-based and will share facilities and resources with the Cell Therapy teams. Primary responsibilities will include: Design, development, characterization and documentation of analytical methods for the phenotypic characterization of genome-edited cell therapy products. etc.

Business Intelligence Analysts (BIA I & II) play a meaningful role in achieving our team’s goal of exceeding customers’ expectations with leading edge data management and data-driven insights and applications. A Glimpse of What Your Day-to-day will look like: Design, develop and administer a system for self and others to evaluate appropriateness of data for analytic hypotheses and applications. Develop and direct a process to clean and integrate complex healthcare datasets in order to create the data foundation for further analytics, client applications, and the development of key client insights. Contribute client team meetings for client engagements and strategic projects requiring complex data management support. etc.

Prepare and ship the important materials used in sample collection to meet our client’s specifications. Essential duties include but are not limited to: Kit Manufacturing: Prepare Sample Collection Kits per Standard Operating Procedures and Project Operating Procedures. Assemble and label Kit Components; including collection tubes, vials, documentation, and boxes per specific Assembly Instructions. Aliquot reagents using Aseptic Technique. Complete Batch Records and supporting documentation. etc.

What to expect day to day: Create specifications for derived/analysis datasets. Program analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS. Generate SDTM domains, ADaM datasets, and Define.xml files. Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. Perform quality control for SAS programs and other study documents (e.g., presentations and reports). Document the quality control review process. Review output across programs to ensure consistency. etc.

Poseida is seeking an outstanding candidate to join the immuno-oncology team. The Research Associate will support the development of chimeric antigen receptor (CAR-T) cellular therapies against cancer and will be involved in bench work, laboratory studies, and the coordination of research projects with the assistance of a senior lab member and/or lab director. Responsibilities: Support preclinical development of CAR-T cellular therapies. Studies may include work with molecular cloning, tissue culture, cell isolation from blood products, virus production, and cell separation. Plan and execute flow cytometry based assays for characterization of cellular products and analysis of tissue samples from animal studies. Plan and execute in vitro cell based immunoassays to functionally characterize CAR-T product.

Poseida is seeking an outstanding candidate to join the Research Operations team. The Lab Technician is responsible for providing broad support for research personnel by maintaining lab facilities, carrying out basic lab equipment maintenance, washing and autoclaving glassware, coordinate collection of biohazard/chemical waste, and replenishing lab supplies. Responsibilities: Set up and carry out daily operational maintenance of lab equipment. Coordinate routine equipment maintenance and preventative maintenance with various vendors. Provide immediate support and troubleshoot issues that arise in the labs (freezer leaks, centrifuge malfunction, incubator contamination, etc.). Conduct daily lab inspections to look for equipment issues (alarms, leaking freezers, etc.), help create a safe lab work environment, and communicate safety violations or issues encountered to Research Operations team.

The Research Associate I or II, CMC-Analytical – Cell Biology, will work in the Cell Therapy Bioassay/Immunoassay/Flow Cytometry group of Precision BioSciences. This individual will provide biologic analytical support for Product Sciences and Cell Therapy Process Development projects. The position will contribute to development efforts for CART-cell projects by providing sample preparation and analysis in a timely manner.  This position is lab-based and will share facilities and resources with the Cell Therapy teams. Primary responsibilities: Design, development, characterization and documentation of analytical methods for the phenotypic characterization of genome-edited cell therapy products using multi-color flow cytometry, immunoassay and bioassay.

The Bioprocess Associate II is responsible for all aspects of cell culture process development and validation as well as technology transfer, including process optimization, scale-up, characterization and validation studies, toxicology material production, process transfer to manufacturing, and production support. This individual will also be responsible for analyzing and summarizing the data in technical reports and presentations and troubleshooting as needed. Responsibilities: Design and execute experiments, including shake flasks, production bioreactors, and harvest operations, to support the development of biologics products. Complete documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records. Analyze experimental data for process understanding and further improvements, draw conclusions and interpret results using statistical tools, including media and process development, process characterization and validation. Contribute to authoring of protocols, operating procedures and technical reports ensuring timely and accurate completion.

In this role, you will contribute to the company’s efforts to develop next-generation cell therapies in solid tumor malignancies. Specifically, you will be part of a preclinical development team focused on engineering approaches to enhance CAR T anti-tumor activity. The successful candidate will have a strong immunology background and will be expected to work in a collaborative cross-functional team environment, perform experiments, organize and analyze results, communicate effectively and present findings in team meetings. Responsibilities: Employ viral-based strategies for the genetic modification of T cells with chimeric antigen receptors (CARs). Culture and characterize CAR T cells. Plan and execute in vitro functional assays with human T cells according to project timelines and goals. Assist with design of murine models/experiments to evaluate CAR T cell function in vivo.

As the Associate Scientist/Senior Associate Scientist of the Bioanalytical Sciences team, you will be responsible for developing and validating bioanalytical methods to support our gene therapy products pipeline.  You will have the opportunity to collaborate with many different groups across the organization, including Research and Early Development, Quality, and Clinical Development and may oversee Contract Research Organizations to ensure that all applicable bioanalytical test methods are appropriate for the stage of non-clinical and/or clinical development. Responsibilities: Develop, qualify and/or validate robust bioanalytical methods (ligand binding and/or cell-based assays) to support the Company pipeline. Troubleshoot and resolve analytical method and instrument issues to successful resolution. Keep detailed, accurate testing records and assure that laboratory equipment is calibrated, standardized, and monitored, as appropriate. Author technical documents (analytical method qualification/validation/transfer documents, technical reports, SOPs, etc.).

This position is responsible for performing routine release and stability testing of final product following cGMP regulations and Sanaria SOP. This position also requires performance of in vitro assay, Viability assay and other QC tests. Responsibilities: Processing and conducting immuno-assays on preclinical and clinical product. Generating and maintaining documentation as per Sanaria documentation procedure. Writing and executing new SOP and protocols. Using technical proficiency and independent thought to collaborate with others to implement new assays. Adhering to industry and government standards regarding aseptic technique and tissue culture practices. Maintaining lab materials inventory and equipment’s.

This is a Laboratory Bench Position for routine/non-routine testing and development/validation of new product testing. Responsibilities: Develop/Optimize/Validate analytical test methods and write protocols/technical reports/test methods in a cGMP environment to support R&D product pipeline requirements. Evaluation of contract laboratory test method validation reports for completeness and adherence to cGMP/USP standards. Perform non-routine evaluation and testing related to investigations and technology. Perform routine laboratory testing. Review analytical data for completeness, accuracy, and compliance. Provide training regarding test methods, equipment, and compliance. Other laboratory duties as assigned.

Seer’s new Formulations Research Associate will be responsible for fundamental laboratory organization activities, including inventory, stocking, and the cleaning of laboratory glassware. Responsibilities: Laboratory organization – stocking, inventory and cleaning of laboratory glassware. Support our characterization efforts and execute standard characterization protocols (DLS, XPS, TEM). Assist with materials synthesis, helping to set up reactions and purify synthesized materials. Implementing standard operating procedures for current materials. Effectively present data internally to other Seer scientists and technologists. Enable the efficient operation of our fast-paced laboratory. Execute standard SOPs reliably. Proficiency in sample prep methods for materials characterization. Work with the broader Formulations team in the development of cutting-edge materials.

Position Summary: Position consists of assembling and inspecting medical devices in a clean room environment while under general supervision in accordance with specific work instructions and SOPs. Assembly and inspection sometimes done under a microscope. This position requires the ability to work with small tools and assemble small components using a high degree of dexterity and accuracy. This position requires direct contact with an implantable medical device. Essential Job Duties and Responsibilities: Must be able to work under direct supervision and take work instruction from Supervisor and Leads, work cooperatively and productively within a team environment. Ability to do repetitive tasks, Detail-Oriented and adherence to Nordson’s Safety Policy. Read, Understand and follow Standard Operating Procedures without deviating from the outlined process after training has been completed. Ability to work on Development Department process steps with significant Technician oversight. etc.

The Product Development Technician Supervisor is responsible for planning and directing daily activities, in coordination with the Development team, of personnel focused on Development assembly. The supervisor supports goals and objectives according to GMP’s, SOP’s and established policies, practices, procedures, quality, and cost standards. The role focuses on continuously improving efficiencies and working cross functionally to achieve overall company objectives. Essential Job Duties and Responsibilities: Participate in Development project planning to understand upcoming Development needs, changes in schedules, current challenges, and space/equipment allocation to help establish strategies to meet team goals. Act as a cross functional liaison for Development and Operations personnel resource communication and alignment. Manage personnel problems/concerns effectively and act as the primary point of contact for personnel feedback. etc.

Assemble finished goods according to work instructions while maintaining outlined quality procedures. Essential Job Duties and Responsibilities: Assemble finished goods according to work instructions. Sort defective parts as directed by quality control. Able to work in a clean room environment. De-gate parts as required. etc.

This position is primarily responsible for the set up, troubleshooting, and up-time of various automated and manual packaging equipment. The Product Equipment Technician (PET) works to develop and enhance the programs and setup on these machines to increase accuracy, efficiency, and throughput. The PET will also set up and program automated de-gating equipment used at the press during plastic injection molding operations, and will be instrumental in the development and refinement of programs and processes used by these robotic devices. The PET works daily in the company’s ERP system (IFS) to verify and enter data while ensuring the timely completion of all assignments. This position will ensure proper line clearance of all equipment prior to the start of any new Shop Order while ensuring all packaging equipment is properly set up to accurately and repeatedly produce the required bag sizes, labeling, and part count while validating that the bag appearance and its contents meet the quality expectations of Value Plastics, Inc. Furthermore, this position will serve as a back-up for other responsibilities such as visual AQL inspection and part cleaning operations. etc.

The Packaging Technician performs routine packaging operations for the production of pharmaceutical products; operates packaging line equipment according to established SOPs and department procedures. Duties and Responsibilities: Prepares and cleans room, equipment, facility and documents for manufacturing and packaging process. Verifies calculations, process steps and yield. Ensures that processes, tools, products and materials meet established quality standards and requirements. Notifies management when inventory fails below certain levels. Assists in the assembly and disassembly of process equipment as necessary. Examines sample of finished product per batch record instructions for conformance with specifications. Notifies supervisor of manufacturing / packaging deviations and assists with proper resolution/documentation. etc.

The Reagent Test Assistant will perform testing of various calibrators, controls, and additional reagents required to support company produced and OEM analyzers, by means of verbal and/or written instruction under the supervision of the Group Leader/Supervisor. Train in the setting up, qualification, operation and troubleshooting of various analyzers and lab equipment. Record and report results as to whether the reagent/control has met specification to the Group Leader/Supervisor of Test lab. Train in performing titrations, pH measurements, flame photometry, microbial culture test and viscosity. Assist in cleaning of Test Lab to ensure work area is neat and safe. Read, write and able to follow instructions in English. etc.

The Formulation Operator will work on our First Shift and perform batch processing of various calibrators, controls, and additional reagents required to support company produced and OEM analyzers. Essential Responsibilities: formulation of various solutions including staging of tanks, weighing and mixing of chemicals per assembly procedures (AP's) and final batch adjustment and transfer of solutions. Perform incoming inspection of raw chemicals upon receipt, maintenance of formulation equipment and cleaning as needed. Ability to accurately document and complete records of batch formulations. etc.

The Receiving Replenishment Associate's is responsible for maintaining raw inventory within the raw material warehouse area. As part of the Receiving Team, the Replenishment Associate will be responsible for (1) the moving of raw material from the Receiving dock to the warehouse, (2) the consolidating of raw material in the warehouse, and (3) the picking and delivering of raw materials to the manufacturing floor. The Replenishment Associate will use documented procedures and good judgement to ensure inventory is stocked in an optimum manner, controlled, and ready for picking. Essential Responsibilities: Essential Responsibilities are to ensure the accurate movement (stocking, replenishing, consolidating, blocking, fulfilling) of materials and products within the Distribution Department and report any /all batch number or quantity discrepancies related to Distribution materials. etc.

Testing and laboratory operational support for Quality Control (QC) Good Manufacturing Practice (GMP) functions. Role focuses on support activities such as routine testing, sample and buffer preparation, laboratory inventory, waste management, material inspection, and general laboratory support. This position will be a Sunday - Thursday 8-5 p.m. schedule. Main Job Tasks: Sample receipt/login/inspection. Routine testing support as needed. Utility and cleaning sample testing via Total Organic Carbon (TOC) analyser. etc.

Filling of insulin and media preparations under aseptic conditions and operation of inspection equipment to achieve production goals. Accountabilities: Work in a safe and environmentally responsible manner. Operating, monitoring and controlling equipment, systems and processes associated with the Vial/Cartridge filling and inspection lines. Achieving production goals. Maintaining aseptic areas and performing sanitizations and environmental monitoring. Actively participate in and support event response. Reviewing and authoring Standard Operating Procedures (SOP’s) and other documents as required. etc.

We’re seeking an energetic and self-directed person to join our Global Optimization Downstream team in the US. Your primary purpose is to have a focused effort on optimization of the downstream production processes to liberate capacity, reduce the variable cost, and improve product quality and robustness. You will contribute to Novozymes build-up in scientific and technical knowledge within downstream processing. In this role you’ll make an impact by: Testing improvement hypothesis at small scale and upscaling ones that prove successful. Leading projects to improve economies and capacities. Working together with Process Engineering and Operations to realize gains. etc.

Performs the physical or administrative tasks involved in the shipping, receiving, storing, distributing and order fulfillment of merchandise, products, materials, parts, supplies and equipment. Checks goods received and for distribution against purchase orders or invoices, maintains records of goods and rejects unsatisfactory items. Packages and prepares products and merchandise for final shipment and posts weights and shipping charges. Lifts heavy items and may operate a forklift. Prepares and maintains records of merchandise shipped. Reviews customer orders, examines, stocks and distributes merchandise, products and materials in inventory warehouses, distribution centers or manufacturing lines. Initiates, maintains, and compiles records associated with ordering, receiving, storing, issuing, and shipping materials, supplies, and equipment by performing the following duties: Compares nomenclature, stock numbers, and other listed information on packing slips to verify accuracy of purchase orders and shipping orders. etc.

The Sales Associate is responsible for providing a wide variety of field sales support within an assigned geography while developing to become a sales specialist. Essential Responsibilities: Develop the required technical, clinical and sales competencies through the completion of the sales associate development program in order to qualify and meet the expectations of becoming a Sales Specialist within 18-24 months. Provide coordination and logistic support in properly ordering, transporting, setting up and reassembling surgical instrument sets inside sterile processing departments at hospitals and surgery centers. Act as a product support consultant to surgeons and operating room staff during surgical procedures in the safe and proper use of NuVasive® products and related surgical techniques. Support and contribute to the growth of revenues in assigned Sales Specialists territories through delegated business development activities with surgeons, hospitals and related staff. etc.

Initiates, maintains, and compiles records associated with ordering, receiving, storing, issuing, and shipping materials, supplies, and equipment by performing the following duties. Compares nomenclature, stock numbers, and other listed information on packing slips to verify the accuracy of purchase orders and shipping orders. Compiles data from sources such as contracts, purchase orders, invoices, requisitions, and accounting reports and writes, types, or enters information into computer to maintain inventory, purchasing, shipping, and other records. Verifies inventory computations against physical count of stock and adjusts errors and reports documenting reasons for discrepancies with proposed corrective action. Compiles and maintains manual or computerized records such as material inventory, in-process production reports, and status of material locations. Compiles information on receipt of disbursement of material, equipment, merchandise, or supplies, and computes inventory balance, price, and cost. etc.

As the Research Associate I, Biochemistry, your responsibilities include: Perform a variety of routine and non-routine research assignments as supervised by a PhD scientist. Conduct routine molecular biology bench work (e.g. recombinant DNA techniques, construct generation and testing). Perform routine eukaryotic cell culture (e.g. cell passaging, viability determination and transfection). Purify recombinant protein samples from cells, using standard lysis and chromatographic techniques and characterization (e.g. SDS-PAGE, Western blotting and thermal shift assays). Keep detailed records of samples, experimental results in lab notebook and digital systems. Analyze and summarize data, present at internal meetings, and communicate regularly with managers and coworkers on experiment progress. etc.

The Regulatory Operations Specialist is responsible for assisting the Regulatory team in QC, document management, and submissions. This is a team and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory team. This position requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast-paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions. etc.

The purpose of the position is to provide technical expertise in the area of pharmaceutical microbiology. The position functions in a cooperative effort to provide quality control and assurance to the operational departments involved in the manufacture of pharmaceutical products. Responsibilities: Conduct routine environmental and systems monitoring of manufacturing and laboratory areas. Conduct general laboratory experimentation in compliance with the instructions provided in approved SOP’s to determine appropriate action. Follow policies and assists in the development of new procedures and/or documents. Maintain records of experiments performed and results obtained including appropriate calculations. Assist in the interpretation of data as require and conduct accurate and precise experimentation and complete. etc.

The Process Engineer I, with guidance, performs various duties related to optimization and analysis of production processes, new products, processes and technology transfers. Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products. Perform or assist on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review. Process Engineering duties within a single location. Make decisions within guidelines and policies. Follow established procedures to perform assignments, with general instructions on the process and desired outcome. Work is reviewed for soundness of technical judgment and accuracy. etc.

Responsibilities: Translate critical healthcare information and test orders from test request forms into database accurately and timely. Review received orders for required elements and effectively communicate missing elements. Ensure a high level of quality throughput. Complies with applicable CLIA and HIPAA regulations. etc.

Principal Duties and Responsibilities: May perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs and work instructions. Accurately collects and records raw data in logbooks and on worksheets. May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable. May be required to operate autoclave, depyrogenation oven or other specified laboratory equipment. etc.

Principal Duties and Responsibilities: Independently conduct testing according to written instructions. May be requested to conduct more involved studies. May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation. May conduct routine testing per NAMSA SOPs as well feasibility, protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP, etc. Works with management to ensure large studies are completed on or before the due date. Prepare and maintain the reagents required for testing. May mentors and train staff in general laboratory testing as well as offering more complex instrumentation training. etc.

Design and develop new cartridge prototypes, working with biosensors, filters, conjugate pads, microfluidics, device programming, etc. to enable specific biological assays on the eLab platform. Design processes required to manufacture product components by developing fixtures (CAD, Laser Printer, 3D Printer, Solidworks etc.), installing necessary components on machinery (Vacuum, Pressure Gauge, Pressure Regulator etc.), scripting robotic liquid handlers, drafting qualification requirements, and writing quality documentations. Design and execute biological wet lab experiments using ELISA, enzymatic assays, chromogenic assays, fluorescence/chemiluminescence. Work with electrochemical (CV, chronocoulommetry) and analytical (FTIR, Raman) tools to characterize biosensors and their performance. Develop quality control methods and implement them in the quality system. etc.

Summary: The Process Engineer II is responsible for developing, implementing, and troubleshooting new methods used in manufacturing in support of the release of new products. This individual will assist in design, development, and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. This individual may establish operating equipment specifications and improve manufacturing techniques. In addition, this individual is involved in new product development, process improvement, and design transfer activities, and may serve as a Process Development lead on project teams. Essential Responsibilities: Develop methods for the manufacturing and use of NanoString products. Develop and draft SOPs, Batch Records, Specifications, and other documentation associated with process transfer to a Manufacturing environment. Assist with performing and documenting Risk Assessments. Assist with design, document and summarize Verification and Validation studies. Draft protocols, experimental summary reports, quality documents and other scientific literature associated with projects. etc.

Executes the preparation and qualification of molecular diagnostic reagents. Performs Quality Control tests on new incoming shipments of raw materials and small scale manufacturing procedures (formulations and dispensing) reagent. Reviews data obtained for compliance to specifications and reports abnormalities. Maintains and improves QC documentation pertaining to raw material specification, reagent qualification, and QC testing. etc.

The Equipment Laboratory Technician will join the QC Equipment team in the Operations department to support the equipment used in the clinical laboratories. Responsibilities will include activities related to the maintenance of accessory equipment used in the Operations lab. PRIMARY RESPONSIBILITIES: Receive and label new equipment according to department procedures. Update and upkeep equipment inventory. Coordinate calibration schedule for all accessory equipment with appropriate in-house personnel or outside vendors. Execute and document maintenance performed on accessory equipment based on recommended intervals. Maintain calibration and maintenance records. etc.

At Natera we are pushing the limits creating exciting products and changing lives. We are seeking a highly motivated and team oriented individual to join the Scientific Operations team as a Clinical Sample Associate 1 to be a part of this exciting team! The ideal candidate must be detail-oriented and have an outstanding ability to perform routine laboratory research and development services. The Clinical Sample Associate 1 will work with a multidisciplinary team in a high-performance environment. PRIMARY RESPONSIBILITIES: You will work primarily with the R&D Scientific Operations team maintaining commercial sample operations for research use. Manage commercial samples transfer into R&D biobank. Verify eligibility for research use based on retention policies, patient opt-outs, and legal requirements. etc.

Natera is currently seeking a Clinical Laboratory Associate I (Temporary) to analyze laboratory specimens following the standard methods and procedures while maintaining equipment and instruments in good operating condition by troubleshooting malfunctions as needed. PRIMARY RESPONSIBILITIES: Assists in testing of patient samples according to standard operating procedure in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Follows GLP (good laboratory practice): maintain cleans and organized work space. Completes training and other deadlines on time. Recognizes and escalates equipment malfunctions; troubleshoots common errors on the lab floor. Recognizes, documents, and escalates protocol deviations in lab to lead/supervisor. Communicates with team and other departments (including via e-mail). Provides feedback on day-to-day schedule and tasks to lead/supervisor. etc.

Primary Responsibilities: Perform a variety of tasks including repetitive and non-repetitive production which may include assembly of components, kitting of parts and configuring assemblies. Conduct quality inspections on in-process materials. Complete documentation and other paperwork as part of the production process. Assist with stockroom and shipping work as required. Stay up to date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers. etc.

As a Clinical Laboratory Technologist - Flow Cytometry you will work under general supervision. You will be responsible for performing highly complex laboratory testing procedures. You will figure out acceptability of specimens for testing, prepare clinical specimens and identify specimen related problems. In this position, you will need to analyze specimens and review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations. Documents all corrective actions taken when test systems deviate from the laboratory’s established performance specifications. Demonstrates initiative in making suggestions to improve efficiency and productivity and provides consistent feedback. etc.

As a Clinical Laboratory Technologist – FISH you will work under general supervision. You will be responsible for performing highly complex laboratory testing procedures. You will figure out acceptability of specimens for testing, prepare clinical specimens and identify specimen related problems. In this position, you will need to analyze specimens and review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations. The shift for this position will be Friday - Monday days, days, 10hr Shifts. Documents all corrective actions taken when test systems deviate from the laboratory’s established performance specifications. Demonstrates initiative in making suggestions to improve efficiency and productivity and provides consistent feedback. etc.

As a Clinical Laboratory Technologist Flow Cytometry you will work under general supervision. You will be responsible for performing highly complex laboratory testing procedures. You will figure out acceptability of specimens for testing, prepare clinical specimens and identify specimen related problems. In this position, you will need to analyze specimens and review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations. The shift for this position will be Monday - Friday 11:00pm - 7:30am. Documents all corrective actions taken when test systems deviate from the laboratory’s established performance specifications. Demonstrates initiative in making suggestions to improve efficiency and productivity and provides consistent feedback. etc.

As a Histotechnologist you will work under general direction to precisely and accurately performing a variety of routine and specialized histology techniques and procedures. In this role, you will receive specimens, prepare them for testing and analysis, and perform filing to finish the case. You will research, troubleshoot, and resolve histology related inquiries and problems within the laboratory. This position requires you to produce the highest quality of embedding, microtomy, tissue grossing, tissue processing, and H&E staining, special staining and equipment maintenance. Receive specimens of tissue and ensure proper accessioning and labeling of all tissue samples. Process paperwork associated with accessioning and reporting. Prepare tissue specimens with chemicals, slicing, and mounting on glass slides for microscopic examination and analysis. etc.

Nexcelom has an immediate opening for a Sales Development Representative [SDR] in our Lawrence, Massachusetts Headquarters. The SDR will partner with marketing and sales to grow revenue and drive in-house lead generation, appointment setting, lead qualification, remote demos and sales support to the Field Sales team. This position requires heavy outbound phone calling, qualification, consultative selling skills and tight collaboration with the Field Sales team to generate new clients and maintain the existing customer base. The SDR will be expected to manage a pipeline and report on qualification and call activity. etc.

The position involves the performing of routine and non-routine analyses of raw materials, in-process materials and finished products in accordance with cGMP guidelines. The appropriately trained individual may provide training and guidance to other QC Analysts. The individual troubleshoots problems associated with methods and instruments resolving them where possible or seeking guidance/authorization where required. Key Responsibilities: Test and analyze samples in a timely manner in support of project plans in accordance to cGMP guidelines. Review analytical data for compliance with specifications and cGMP guidelines. Assist in development of experimental procedures and protocols. Develop/revise documentation such as SOP, testing procedures and material specifications. etc.

Working with other members of the manufacturing team, this role supports the successful tech transfer and operational readiness processes including the GMP manufacture and release of cell therapy products. Key Responsibilities: Supports the successful tech transfer and operational readiness processes using knowledge of cGMP regulations to ensure manufacturing readiness. Supports the GMP manufacture and release of cell therapy products; follows all processes and procedures related to operations in full compliance with cGMP, CFRs, site quality systems and company policies; and promotes a culture of quality and compliance. Performs process unit and support operations described in standard operating procedures (SOPs) and batch records including: media and solution preparation, cell drug substance preparation; and drug product fill operations. Performs all tasks associated with the manufacture of commercial product following batch records and SOPs. Works as part of a small team to execute GMP runs in close collaboration with process development and quality. etc.

The Product Development Technician Supervisor is responsible for planning and directing daily activities, in coordination with the Development team, of personnel focused on Development assembly. The supervisor supports goals and objectives according to GMP’s, SOP’s and established policies, practices, procedures, quality, and cost standards. The role focuses on continuously improving efficiencies and working cross functionally to achieve overall company objectives. Essential Job Duties and Responsibilities: Participate in Development project planning to understand upcoming Development needs, changes in schedules, current challenges, and space/equipment allocation to help establish strategies to meet team goals. etc.

A material handler is responsible for sequencing all WIP, driven by dispatch scheduling, at each relevant machining center to enable work center efficiency and elevate execution of OTD to 90% or greater. Essential Job Duties and Responsibilities: Offloads incoming bar stock. Moves bar stock from storage area into the manufacturing process as required. Reviews machining center daily dispatch reports for machining centers and sequences bar stock in order at the relevant machining center. Transfers bar stock from machining center to machining center to assist operator efficiency. Removes clutter from the process line areas. Removes and disposes of dunnage properly. Empties machining chip hoppers as necessary. etc.

Your mission will be to: Job Duties: Read plates and tubes, as required, to determine the number of organisms in the sample. Record findings on worksheet for verification. Write identification onto plates so that client and sample number can be tracked. Pipette sample solution into tubes or plates according to the analysis process being performed. Pour the agar into plates or tubes to begin the growth process. Prepare sample for analysis by recording, weighing, and blending. Collect plates and place them in the incubator for the specified amount of time and temperature. Prepare media and broth for use in pathogen testing as required. etc.

The incumbent is responsible for performing chemical analysis on food/pharmaceutical samples. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the samples to obtain the needed results. This position reports to the Supervisor of Chemistry. Job Responsibilities: Analyses w/Extractions (Cholesterol, FAP, ICP, MOJO, FFA, etc.) Ensure that proper analysis methods are conducted on the appropriate samples. Maintain chemistry quality control records and procedures for each test. Extract desired components from samples with appropriate processes such as distillation, solvent extraction and acid digestion, so that concentrations can be determined. Calculate the concentration of components present in samples and post results. Wash glassware as needed and prepare samples as needed. etc.

Your mission will be to: Job Duties: Read plates and tubes, as required, to determine the number of organisms in the sample. Record findings on worksheet for verification. Write identification onto plates so that client and sample number can be tracked. Pipette sample solution into tubes or plates according to the analysis process being performed. Pour the agar into plates or tubes to begin the growth process. Prepare sample for analysis by recording, weighing, and blending. Collect plates and place them in the incubator for the specified amount of time and temperature. etc.

The incumbent is responsible for performing chemical analysis on food/pharmaceutical samples. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the samples to obtain the needed results. Job Duties: Analyses w/Extractions (Cholesterol, FAP, ICP, MOJO, FFA, etc.) Ensure that proper analysis methods are conducted on the appropriate samples. Maintain chemistry quality control records and procedures for each test. Extract desired components from samples with appropriate processes such as distillation, solvent extraction and acid digestion, so that concentrations can be determined. Calculate the concentration of components present in samples and post results. etc.

This position is responsible for cosmetic part quality, dimensional charting, paperwork completion, and submission of molded component lots to Quality Assurance for final audit approval. ESSENTIAL FUNCTIONS PERFORMED: Performs start-up dimensions, as required. Packages and weighs the product and makes labels. Inspects parts visually and uses measuring tools; documents results and ensures compliance to drawings and specifications; performs testing of products, as required. etc.

Performs any of a variety of medical assembly and processing tasks as a production team member. ESSENTIAL FUNCTIONS PERFORMED: Assembles medical products on an assembly operation, performing a variety of tasks on a rotating basis. Ability to rotate through the assembly line. Performs on-line and in-process visual inspection of products to ensure specifications per work order and procedure are followed. Assists Team Leader and Technicians with product and/or machine change-overs. Ensures product assembled meets quality standards. etc.

Performs a variety of medical assembly and processing tasks as a production team member, including performing various technical assembly tasks. ESSENTIAL FUNCTIONS PERFORMED: May include but not limited to performing one or more processes within quality specifications while visually monitoring the machines/equipment used to ensure proper function. Ability to rotate through the assembly line, performing all production assembly operations. Performs on-line and in-process visual inspection of products to ensure it meets specifications per work order and procedure instructions. etc.

Responsible for developing, characterizing and validating manufacturing processes to produce biochemical assay plates and related consumables. DUTIES AND RESPONSIBILITIES: Review existing manufacturing processes to determine if changes are needed to improve quality and quantity of products, reduce any variations between lots produced and expand product portfolio. Make recommendations to manager to improve/enhance processes as needed. Design and conduct process experiments on manufacturing and pilot scale equipment to determine if/how changes affect product(s) properties. In accordance with standard operating procedures, provide documentation of all experimental results and present findings to manager and other appropriate staff. etc.

MRIGlobal is seeking a highly motivated chemist to join our chemistry program in the Physical Sciences Group. The position will involve providing analytical and logistic support for US Government clients requiring characterization of unknown samples. The position will require the use of a variety of techniques for the identification of unknown materials and impurities/degradants (e.g., GC-MS, LC-MS, DART-MS, Raman, FTIR, XRF, etc.). The chemist may also be responsible for instrument calibration and maintenance, data processing and review, and assisting with drafting monthly or final reports. etc.

As a Software Engineer I at Minnetronix, you’ll design, implement and test real-time embedded medical device software and supporting applications and prototypes. Working under close engineering supervision on a cross-functional team, you’ll help bring medical devices from concept through development and into production . We have a broad client base so project assignments will span an array of products, be broad in nature, and require creativity and ingenuity. Essential Duties and Responsibilities: Assist in definition, analysis and allocation of requirements. Implement source code that meets product requirements in compliance with applicable coding standards. Contribute to analysis, review and evaluation of design alternatives and failure mode analyses. Assist in the creation and document ation of module-level software architecture and all aspects of software design. Unit test source code using IDE’s, debuggers, emulators, communication analyzers, scopes, and logic analyzers. Install, qualify, and configure development tools and utilities. etc.

Reporting to the Senior Manager of US External Manufacturing, the Specialist/ Engineer II will be part of a team responsible for Moderna’s manufacturing activities at 3rd-party contract manufacturing organizations (CMO). Here’s What You’ll Do: Ensure operational and technology transfer activities are performed completely and compliantly at CMOs to deliver a quality product and meet Moderna requirements. Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality. Review instructions relating to external production operations and ensure their strict implementation by the CMOs. Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna’s requirements. etc.

The individual in this role will be part of a cohesive team responsible for supporting GMP DNA-based medicines for evaluation in human clinical trials focusing primarily in DNA Plasmid manufacturing. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bioprocessing equipment and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts. The anticipated time frame for this assignment is six months. etc.

The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations at the Moderna Norward facility in accordance with established processes and procedures. The successful candidate will be able to document and communicate their operational observations clearly and efficiently. They will be curious to learn and able to demonstrate a high degree of working flexibly. Here’s What You’ll Do: Safely transport product, equipment and materials (buffers, drug substance) from the warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements in support of the manufacture of mRNA medicines. etc.

The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations at the Moderna Norward facility in accordance with established processes and procedures. The successful candidate will be able to document and communicate their operational observations clearly and efficiently. They will be curious to learn and able to demonstrate a high degree of working flexibly. Here’s What You’ll Do: Safely transport product, equipment and materials (buffers, drug substance) from the warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements in support of the manufacture of mRNA medicines. etc.

Responsible for sample transfers and preparation in the Micro lab as well as completing analysis by setting-up laboratory samples and performing routine tests to determine microbial characteristics of Salmonella, E.coli, and Listeria. Performs samples for plating and operates dilutor.

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help: Identify and meet U.S. customer, consumer, and HCPs needs via phone, email, or fax by clarifying issues, researching and exploring answers or alternate solutions to all inquiries within set timelines for all business units. Maintaining the CRM database by logging call details accurately in accordance with department guidelines to report various trends to senior leadership. Maintaining current thorough knowledge of all business units and product portfolios, marketing campaigns, pricing, website information, PAP programs, FAQs, and other relevant programs and information to ensure One Mylan is accurately represented as a shared service. etc.

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help: Develops business plan for assigned territory that is consistent with Mylan’s sales plans, strategies and objectives. Conducts quality sales presentations to all targeted customers. Achieve quarterly sales goals within territory while adhering to all ethical sales practices and required regulations. Understands and demonstrates targeting principles. Develops pre-call planning strategy for key targets. etc.

Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join our research and development team as a full-time Data Analyst. This individual will be responsible for assisting in the generation, production and characterization of novel antimicrobial products. Primary responsibilities include maintaining and leveraging data acquired from automated and high-throughput instruments. The ideal candidate will be able to drive the automation of data acquisition from lab instruments, maintain a data warehouse, and derive meaningful insights from large datasets. This individual must be able to communicate effectively in formal and informal settings and be able to work well within a team. Candidates should have a passion for data-driven decision making and bringing life-saving therapeutics to patients. etc.

LogicBio is seeking a highly motivated and scientifically rigorous individual to join our Vector Development and Operations group at either the Research Associate or Senior Research Associate level. This position will focus on developing research vector production methods, vector analytical methods and producing pre-clinical material. Primary Responsibilities: Manufactures research grade rAAV vectors utilizing suspension cell culture in shaker flasks. Executes processes for purification of rAAV utilizing various techniques such as depth filtration, centrifugation, column chromatography and TFF. Performs occasionally analytical tests such as qPCR/ddPCR, SDS-PAGE, infectivity assays. Fills out batch records, and accurately completes documentation associated with preclinical manufacturing. etc.

The GMP Manufacturing Technician I position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements as directed by the departmental supervisor, manager or director. Areas of Responsibility: To perform this job successfully, an individual must be able to perform each essential function satisfactorily. Essential Functions: Perform manufacturing activities according to written protocols, as directed by the departmental supervisor, manager or director. Maintain batch records, equipment logs and other production records as directed per company procedures. Maintain a clean an orderly laboratory environment. etc.

The Assembly Associate I, Consumables will be responsible for: Building of cassettes for use by Engineering, Development, Clinical Studies, and product sales. Following approved cGMP manufacturing instructions and personnel are required to complete a history record of the lot built per company Quality System. Providing feedback on the processes to assure continuous improvement by noting differences in parts, assemblies, tools, fixtures, or process steps. What you will do: Coordinate with other assembly associates daily in support of integration testing, manual instruction development and production process development. All to support a quality process. Hands-on assembly, test and troubleshooting of system builds and re-work. etc.

The Assembly Associate I, Consumables will be responsible for: Building of cassettes for use by Engineering, Development, Clinical Studies, and product sales. Following approved cGMP manufacturing instructions and personnel are required to complete a history record of the lot built per company Quality System. Providing feedback on the processes to assure continuous improvement by noting differences in parts, assemblies, tools, fixtures, or process steps. What you will do: Coordinate with other assembly associates daily in support of integration testing, manual instruction development and production process development. All to support a quality process. Hands-on assembly, test and troubleshooting of system builds and re-work. etc.

Lundbeck is seeking a Quality Control Associate to support QC testing activities for projects in both the early and late stage of clinical and commercial development. The ideal candidate is detail oriented, organized and will have some experience in a Quality Control or other scientific laboratory or setting. ESSENTIAL FUNCTIONS: QC Sample Shipping and Sample Management. Coordinate and track sample shipments between various departments at Lundbeck and multiple CMOs/contract testing labs including international shipments. Lead a weekly multi-departmental sample shipping working group meeting. Proactively communicate shipping timelines from contract testing labs to other QC personnel and other Lundbeck contacts, as required. etc.

Manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. JOB DUTIES: Maintain Document Change Request/Quality System event databases and Master Documents/List. Maintain Designated Satellite Areas for controlled paper based record management system. Facilitate Client Batch Record Creation/Modifications/Approvals. Issue, maintain and archive Controlled Documentation/Batch Records/Testing Data Sheets/Equipment Log Books/Quality System event documents and Logs. Track and facilitate Periodic SOP reviews. Manage Record/Document Filing system. Proof and edit document changes, as necessary. Assist in client audit preparation and reconciliation. Other duties as assigned. etc.

Job Description Summary: Develop and produce pharmaceutical products via multiple methodologies, follow standard operating procedures, maintain compliance with Good Manufacturing Practices. ESSENTIAL FUNCTIONS: cGMP Active Pharmaceutical Ingredient (API) manufacturing. Conduct lab and pilot scale chemistry methods to synthesize and produce pharmaceuticals. Maintain strict FDA and cGMP compliance. Routinely and effectively maintain laboratory and supplies. Be able to troubleshoot and resolve technical issues along with comprehensive knowledge of hand tools. Follow Six Sigma and Lean manufacturing methods for stream lining and quality production. etc.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.

Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. etc.

This position is responsible for storage of customer products requiring specific environmental conditions. Duties involve cleaning, couriering, shipping, receiving and inventorying. Abide by area work instructions to ensure customer product is stored appropriately and moves to/from customer and to/from Masy with appropriate controls. Accuracy, attention to detail and GMP compliance are key requirements. Duties/Responsibilities: Store product appropriately and enter information electronically into applicable system. Maintain and monitor temperature in chambers during addition and removal of product. Understand temperature and time as they relate to customer storage needs. Clean and maintain the Biorepository facility and chambers. etc.

Medicomp is looking for a hard-working, charismatic, road warrior (we’ll call you an Associate Sales Manager) who is excited about playing an integral part in getting our life-saving products into the hands of the patients that need them. This might be your opportunity to break into the very desired medical device sales field. It is no secret that these jobs are hard to get and you typically need a TON of previous experience to be considered for any opportunity. Well, today is your lucky day, because we want fresh talent. We don’t want the cast-offs from other companies who are simply looking to coast and a collect bare bones paycheck. We want money motivated candidates who are system and process oriented. We want those who have a tremendous desire to rise to the top of the rankings amongst their peers. We want rock stars only! etc.

Medicomp is looking for a hard-working, charismatic, road warrior (we’ll call you an Associate Sales Manager) who is excited about playing an integral part in getting our life-saving products into the hands of the patients that need them. This might be your opportunity to break into the very desired medical device sales field. It is no secret that these jobs are hard to get and you typically need a TON of previous experience to be considered for any opportunity. Well, today is your lucky day, because we want fresh talent. We don’t want the cast-offs from other companies who are simply looking to coast and a collect bare bones paycheck. We want money motivated candidates who are system and process oriented. We want those who have a tremendous desire to rise to the top of the rankings amongst their peers. We want rock stars only! etc.

Medicomp is looking for a hard-working, charismatic, road warrior (we’ll call you an Associate Sales Manager) who is excited about playing an integral part in getting our life-saving products into the hands of the patients that need them. This might be your opportunity to break into the very desired medical device sales field. It is no secret that these jobs are hard to get and you typically need a TON of previous experience to be considered for any opportunity. Well, today is your lucky day, because we want fresh talent. We don’t want the cast-offs from other companies who are simply looking to coast and a collect bare bones paycheck. We want money motivated candidates who are system and process oriented. We want those who have a tremendous desire to rise to the top of the rankings amongst their peers. We want rock stars only! etc.

The role of Digital Marketing Associate will be to manage Medicomp’s presence in the digital universe. This will include Facebook, LinkedIn, PPC advertising, drip campaigns, and CRM management. As the Digital Marketing Associate, you will have the opportunity to hone your SEO and advertising skills alongside a talented team of internal professionals and external consultants who live and breathe marketing. You should have a passion for digital marketing and excel at both technical- and analytical-related tasks, in addition to bringing creativity to the role. You will have a direct impact on driving lead acquisition and management efforts for our sales team by helping to execute both on our marketing plan and advertising campaigns. etc.

This position exists as a support to the manufacturing department. This position labels and delivers all packaging with the correct lot information and ensure that each production team member has the materials that they need to ensure maximum productivity and uptime. What you will do: Label all inner packaging with correct lot information for each machine in operation on a given shift. Apply labels to outer and intermediate packaging for all products on a given shift. Deliver materials as required to each machine in operation on a given shift. Empty the trash and scrap generated from the production cell over the course of a given shift. Assist the team lead with material movement inside the department, including raw materials, finished goods, and WIP materials. etc.

The Center for Radiological Research is seeking a technician to work with scientists studying the health hazards and antimicrobial efficacy of ultraviolet light. They will gain experience in immunohistochemistry, animal handling and husbandry, and ultraviolet exposure techniques. The primary work location will be at the Radiological Research Accelerator Facility at the Columbia University Nevis Laboratories in Irvington, NY. Occasional work at the Columbia University Irving Medical Center may be required.

Responsible for executing experimental protocols and performing elementary data analysis in biopharmaceutical development laboratories. Job Description: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste. etc.

Job Summary: Coordinate and perform cGMP manufacturing operations for manufactured biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products at high quality levels. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP's and batch records. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

Responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean-room, retain records and write reports. May also be responsible for troubleshooting. Job Description: Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures. etc.

The Analyst I is responsible for preparation of reagents and solutions as well as sample processing under required regulatory documentation. Analyzes data, interprets results, and contributes to troubleshooting activities, such inventory of chemicals, washing glassware, waste disposal and/or general cleanup. May provide basic training for other laboratory personnel. Process and/or analyze samples. Prepare and label laboratory solutions. Perform and/or verify calculations related to reagent preparation and/or sample analysis. Conduct sample inventory and verify sample identities. Review information and documentation for accuracy. Prepare study records for archive. Independently create basic experiment plans. etc.

The Analyst II is responsible for preparation of reagents and solutions as well as sample processing under required regulatory documentation. Analyzes data, interprets results, and contributes to troubleshooting activities, such inventory of chemicals, washing glassware, waste disposal and/or general cleanup. May provide basic training for other laboratory personnel. Process and/or analyze samples. Prepare and label laboratory solutions. Perform and/or verify calculations related to reagent preparation and/or sample analysis. Conduct sample inventory and verify sample identities. Review information and documentation for accuracy. Prepare study records for archive. Independently create basic experiment plans. Process and summarize data using applicable software. etc.

Provide administrative support related to writing reports, test procedures, filing, and preparation of studies for archival. Works on assignments that are complex in nature in which considerable judgment and initiative are required in resolving problems and making recommendations. ESSENTIAL FUNCTIONS: Works in conjunction with Management/PSI and Quality to ensure report writing process is accurate and completed in a timely manner. Provides support for creation of reports, tables, and transmittals to be published by Management/PSI. Prepares studies for archival based on scientific department requirements. etc.

The Analyst II will be responsible to help extend our active hours by working a 2nd shift. Primary duties are preparation of reagents and solutions under required regulatory documentation, initiating and finishing sample analysis, monitoring results, contributing to troubleshooting activities. Other duties may include performing chemical inventory, and general laboratory activities such as washing glassware, waste disposal and/or general cleanup. With demonstrated progress and initiative, the candidate will also have opportunities for learning other value-added skills. Key Job Responsibilities: Typical responsibilities may include, but are not limited to, the following: Prepare and label laboratory solutions or buffers. Perform and/or verify calculations related to reagent preparation and/or sample analysis. etc.

The in vivo pharmacology group is seeking an experienced and motivated Research Associate to join the growing team in Kite Emeryville. The candidate will join an established group, playing a key role in generating in vivo data in support of multiple programs utilizing engineered human T cells with chimeric antigen receptors (CARs). Responsibilities will include, but are not limited to: Perform in vivo studies to evaluate the efficacy of engineered T cells in mouse tumor models. Establish tumor models through SQ or IV inoculation, administer T cells IV, and dose mice with multiple agents IP or PO. Monitor in-life study measurements (tumor volume/burden, body weight), and enter data in associated software programs. etc.

Krystal Biotech, Inc is seeking a highly motivated and dynamic GMP Manufacturing Associate to support launch of and manufacturing at our Pittsburgh GMP facility. The ideal candidate will have foundation experience in upstream and/or downstream biologics or gene therapy manufacturing. Responsibilities will include, but are not limited to, the following: Develop and execute SOPs. Execute and report IQ/OQ for equipment. Operate and maintain manufacturing equipment. Perform process for manufacturing drug product for clinical trials. Clean and maintain GMP facility. Engage with process development team for tech transfer of improvements/scale up. etc.

Lead, train, and direct the daily activities of the Packaging/Manufacturing Departments by following all applicable Standard Operating Procedures/cGMP’s as well as maintain a safe work environment. Key Duties & Responsibilities: Supervise day to day operations of Manufacturing/Packaging. Assist with daily planning and scheduling to ensure proper workflow. Monitor, organize, and execute all functions associated with packaging of pharmaceutical commercial products and assuring compliance with cGMP, SOP, FDA, DEA, and OSHA rules and regulations. Work directly with management and group leaders to ensure appropriate follow through of the weekly planning schedule. etc.

Operators are responsible for operating special purpose machines or industrial equipment to specifications on production basis in typical oral solid dose pharmaceutical manufacturing. Processes include dispensing and weighing of materials, using automatic and semi-automatic equipment for tablet manufacturing, combining materials to make blends and solutions, and packaging of finished product. JOB RESPONSIBILITIES: Ensure the proper set-up and operation of standard pharmaceutical process equipment such as Granulators, Blenders, Mills, Tablet Presses, Tablet Coaters and Packaging. etc.

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards. JOB RESPONSIBILITIES: Daily activities include review of documentation generated during method development, method validation, stability testing, routine testing and other analyses. The individual will interface with their supervisor, the analytical groups and QA on a daily basis. etc.

Person exhibits aptitude in assisting in the development of topical product pharmaceutical formulations, as well as meeting timelines for the department. JOB RESPONSIBILITIES: Assist in the development of broad range of topical product pharmaceutical formulations including gels, creams, solutions and ointments. Develop pharmaceutical formulations utilizing Quality by Design (QbD) and risk assessment concepts. Contribute and support the analytical efforts and interpretation of data generated from experimental batches. Write technical documents to support regulatory submissions and technical transfers. Interact cross departmentally and provide technical guidance to achieve company objectives. etc.

The following duties are normal for this position; however, they are not to be construed as exclusive or all-inclusive. Other duties may be required and assigned. Essential Duties and Other Responsibilities: Prepare quotations for protocols, bid requests, study revisions, and additions’ using the company’s pricing tools. Complete budget to actual reconciliations at predetermined time points over the course of awarded studies. Assist in making recommendations on desirable proposals based on established financial and operational criteria, as required. etc.

The primary responsibility of this individual is to maintain the overall health and well-being of the rabbits including cage and facility maintenance. This would include the feeding and watering of rabbits, administering treatments, as well as swapping, cleaning, disinfecting, and sanitizing all animal housing units and animal facilities. Responsibilities Include (but are not limited to): Feeding, watering, and administering treatments, including observing and reporting any signs of disease/illness and help to treat minor cases of such findings. Scraping, chipping, and dusting, animal caging units. Swapping/rotating animal. Caging units. Disassembling/assembling, cleaning, disinfecting, and sanitizing all animal caging units including feeders, water bottles, and enrichment items. etc.

This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products. Work on a team of 6 or more analysts. No direct reports. No purchase approval or budget responsibilities. Responsibilities: Perform accurate and timely analysis of in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements. Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution. Document all laboratory testing and maintain accurate and legible notebooks and records. Peer review of data, reports and notebooks. etc.

Complete in-process, final inspection of medical devices and review DHR and record QC Chemistry and Microbiology results. Responsibilities: Read work instructions to complete in-process and final inspections. Use a wide assortment of QC inspection instruments to assure components and devices are manufactured and are functioning in accordance to specifications. Use simple test equipment and record data and interpret its pass/fail status. etc.

We are seeking individuals who are passionate about research, bring out of the box thinking and take bold steps to develop innovative technologies with applications in the ubiquitin research field. Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with protein expression and purification and cloning. Knowledge of the ubiquitin proteasome pathway is desired. etc.

Associate scientist needed in the area of pharmaceutical drug delivery research. Responsibilities include conducting laboratory experiments in support of formulation and process development. Qualified candidates will possess a BS/MS in life Science, chemical engineering or related field or 1-3 years experience in a pharmaceutical or chemistry laboratory. Knowledge of laboratory practices and demonstrated skills in analytical instrumental techniques (e.g. HPLC) are preferred. Excellent communication skills needed for preparing and following standard test methods and reporting experimental results.